[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ischemic-cardiomyopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ischemic-cardiomyopathy":445},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,45,72,96,124,152,182,205,226,252,284,308,333,367,389,426],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100631785",false,"NCT07505199","Safety and Efficacy of FAP iCDC in Ischemic Cardiomyopathy","Safety and Efficacy of FAP-Targeted Immunosuppressive CAR-DC in the Treatment of Ischemic Cardiomyopathy","Inclusion Criteria:\n\n* Age ≥18 years and ≤75 years.\n* Diagnosis of ischemic cardiomyopathy, with at least 3 months of optimized guideline-directed medical therapy (GDMT) at maximally tolerated doses; left ventricular ejection fraction (LVEF) \\\u003C35%; New York Heart Association (NYHA) functional class III-IV.\n* Ability to understand the risks, benefits, and treatment alternatives of immunoregulatory CAR-DC therapy, and willingness to participate in the study; the patient or his\u002Fher legally authorized representative must provide written informed consent prior to study enrollment.\n* Adequate hematologic function defined as: hematocrit \\>30%, lymphocyte count \\>0.5 × 10⁹\u002FL, and platelet count \\>60 × 10⁹\u002FL.\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C1 year due to non-cardiac conditions.\n\nCardiac resynchronization therapy (CRT) implantation within 3 months prior to enrollment or planned CRT implantation.\n\nPercutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 3 months prior to enrollment OR plan to PCI.\n\nPresence of non-ischemic cardiomyopathy, including but not limited to dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, arrhythmogenic cardiomyopathy, peripartum cardiomyopathy, inflammatory or immune-mediated cardiomyopathy, metabolic or genetic cardiomyopathy, or cardiomyopathy secondary to moderate-to-severe valvular heart disease, congenital heart disease, or other non-ischemic etiologies.\n\nPersistent hemodynamic instability.\n\nEnd-stage renal disease (eGFR \\\u003C25 mL\u002Fmin\u002F1.73 m²) requiring or receiving renal replacement therapy (hemodialysis or peritoneal dialysis).\n\nActive autoimmune disease requiring immunosuppressive therapy.\n\nHistory of malignancy.\n\nActive infection, including but not limited to active hepatitis B (HBV DNA \\>1000 copies\u002FmL by PCR), hepatitis C, syphilis, or human immunodeficiency virus (HIV) infection, or uncontrolled systemic fungal, bacterial, viral, or other infections.\n\nPregnant women.\n\nKnown contraindications to the investigational product or study-related procedures.","ALL","18 Years","75 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This study aims to evaluate the safety and efficacy of fibroblast activation protein (FAP)-targeted autologous immunosuppressive chimeric antigen receptor dendritic cell (iCDC) therapy in patients with ischemic cardiomyopathy, and to explore its potential as a novel therapeutic strategy for this disease.",[26,27],"Ischemic Cardiomyopathy","Cell Therapy",[29,30,31],"ischemic cardiomyopathy","dendritic cell","immune tolerance","RECRUITING","2026-07-01",{"date":35,"type":36},"2026-07-02","ACTUAL",{"date":38,"type":36},"2026-05-21",{"date":40,"type":20},"2029-04-01",{"name":42,"class":43},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",1,{"id":46,"slug":4,"hasResults":10,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":44},"100590300","NCT06965621","18F-mFBG Imaging for Myocardial Sympathetic Innervation","An Open-Label, Exploratory, Phase 2 Scintigraphy Study Evaluating 18F mFBG for Imaging Myocardial Sympathetic Innervation in Subjects With Heart Failure and Implantable Cardioverter-Defibrillators","Inclusion Criteria:\n\n* Stable heart failure from ischemic cardiomyopathy, LVEF \\\u003C or = 35%, ICD implantation for at least 12 months\n\nExclusion Criteria:\n\n* Unstable coronary artery disease, no ICD implantation",{"count":52,"type":20},20,[54],"PHASE2","This is a Phase 2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of myocardial sympathetic innervation. The study will examine a group of stable patients with heart failure (HF) from ischemic cardiomyopathy. All subjects will have left ventricular ejection fraction (LVEF) ≤35% and implantable cardioverter-defibrillators (ICD). The primary objectives of the study will be to:\n\n* document the degree to which 18F-mFBG uptake in the heart is reduced (compared to historical controls)\n* characterize the distribution of regional abnormalities in relation to findings on rest\u002Fstress positron-emission tomography (PET) myocardial perfusion imaging (MPI)\n* determine if there are global and\u002For regional differences in myocardial sympathetic innervation between subjects who have and have not experienced an appropriate ICD activation within the previous 12 months Effectiveness of 18F-mFBG will be judged in relation to historical experience with other nuclear imaging agents for cardiac sympathetic innervation imaging such as a 123I-meta-iodobenzylguanidine (mIBG) and 11C-hydroxyephedrine (HED).\n\nSafety data will be collected to identify adverse events \\[AEs\\] and serious adverse events \\[SAEs\\] and characterize the safety profile of 18F-mFBG.",[57,26,58],"Heart Failure","ICD Patients",[60,61,62],"Myocardial sympathetic innervation","PET myocardial imaging","18F-mFBG","2026-06-29",{"date":33,"type":36},{"date":66,"type":36},"2025-11-05",{"date":68,"type":20},"2026-12-30",{"name":70,"class":71},"Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)","INDUSTRY",{"id":73,"slug":4,"hasResults":10,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":10,"sex":15,"minAge":78,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":44},"100587569","NCT06930092","RestoratIon of Myocardial Function by PeRcutaneous cOronary interVEntion in Patients With Ischemic CardioMyoPathy","IMPROVE-ICMP","Inclusion Criteria:\n\n* Subject must be ≥ 19 years\n* Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic or imaging evaluation and PCI and he\u002Fshe or his\u002Fher legally authorized representative provides written informed consent prior to any study related procedure.\n* Subject with LV ejection fraction \\\u003C40% from cardiac MRI\n* Subject with multivessel disease in major epicardial coronary artery disease or their major branches (vessel size of 2.5 mm or more than 2.5mm) considering coronary revascularization\n\nExclusion Criteria:\n\n* Subjects with more than 50% transmural extent of infarction on GE-MRI in more than 25% of the dysfunctional myocardial segments\n* Subject with suspicious of other cardiomyopathy (dilated cardiomyopathy, hypertrophic cardiomyopathy etc.)\n* Subject with recent myocardial infarction within 4 weeks\n* Subject with recent fatal arrhythmia (VT or VF) within 4 weeks\n* Subject with hemodynamically unstable state\n* Subject with complex coronary artery lesions, such as chronic total occlusions, in which complete revascularization is considered unfeasible\n* Subject for whom coronary artery bypass surgery is prioritized over coronary artery intervention\n* Subject with severe valvular heart disease requiring open heart surgery\n* Subject with history of coronary artery bypass surgery or valve surgery\n* Subject with expected life expectancy of less than 1 year\n* Subject considered ineligible for this study based on the investigator's discretion","19 Years",{"count":80,"type":20},158,[82],"NA","To compare the effects of physiology- and imaging-guided PCI combined with optimal medical therapy (OMT) versus OMT alone on the recovery of left ventricular systolic function in patients with ischemic cardiomyopathy and multivessel coronary artery disease.",[26],[86],"percutaneous coronary intervention","2026-04-21",{"date":89,"type":36},"2026-04-24",{"date":91,"type":36},"2025-08-03",{"date":93,"type":20},"2029-04-30",{"name":95,"class":43},"Seoul National University Hospital",{"id":97,"slug":4,"hasResults":10,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":44},"100478536","NCT05511246","Venous Ethanol for Ventricular Tachycardia","Venous Ethanol for Ischemic Left Ventricular Tachycardia","VELVET","Inclusion Criteria:\n\n* Male and female, ages of 18 and 85 years and with a prior ICD implant\n* Diagnosed with ischemic cardiomyopathy: Prior myocardial infarction (pathological Q waves or imaging evidence of regional myocardial akinesis\u002Fthinning in the absence of a non-ischemic cause)\n* One of the following VT events (within last 6 months): a) ≥3 episodes of VT treated with anti-tachycardia pacing (ATP) or anti-arrhythmic drugs; b) ≥1 appropriate ICD shocks; c) ≥3 VT episodes within 24 hr; d) sustained VT below detection rate of the ICD documented by EKG\u002Fcardiac monitor\n* Patients deemed candidates for RF ablation of VT\n* Able and willing to comply with pre-, post-, and follow-up requirements\n* Willing to sign the informed consent\n\nExclusion Criteria:\n\n* Serum creatinine \\>1.5 mg\u002FdL, or creatinine clearance \\\u003C30 ml\u002Fmin\n* Left ventricular (LV) ejection fraction ≤10%\n* Mobile LV thrombus on echocardiography\n* Absence of vascular access to the LV\n* Disease process likely to limit survival to \\\u003C12 months\n* New York Heart Association class IV heart failure\n* Cardiac surgery within the past 2 months (unless VT was incessant),\n* Acute coronary syndrome in the past 2 months (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on EKG)\n* Another reversible cause of VT (e.g. electrolyte abnormalities, drug-induced arrhythmia)\n* Severe aortic stenosis or mitral regurgitation with a flail leaflet\n* Pregnancy\n* Unwilling or unable to provide informed consent\n* Covid-19 positive testing within 14 days of randomization procedure\n* Enrolled, or planning to get enrolled, in another research study during his\u002Fher participation on the Velvet trial","85 Years",{"count":105,"type":20},156,[54],"Comparative effectiveness randomized clinical trial, comparing endocardial radiofrequency ablation alone vs radiofrequency ablation combined with venous ethanol in patients with ischemic ventricular tachycardia -Venous Ethanol for Left Ventricular Ischemic Ventricular Tachycardia -VELVET clinical trial",[109,26],"Ventricular Tachycardia",[111,112,113,114],"Ventricular tachycardia","Coronary veins","Ethanol","Ablation","2026-03-25",{"date":117,"type":36},"2026-03-30",{"date":119,"type":36},"2023-04-12",{"date":121,"type":20},"2028-12-12",{"name":123,"class":43},"The Methodist Hospital Research Institute",{"id":125,"slug":4,"hasResults":10,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":103,"enrollmentInfo":131,"targetDuration":4,"studyType":21,"phases":133,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":151},"100627058","NCT07443696","PET Myocardial Fatty-acid Metabolic Imaging With XTR003 Injection and 18F-FDG to Assess Myocardial Viability in Ischemic Cardiomyopathy","A Randomized, Open-Label, Parallel-Controlled Phase IIb Clinical Trial of PET Myocardial Fatty-acid Metabolic Imaging With XTR003 Injection Integrated With 18F-FDG for the Assessment of Myocardial Viability in Patients With Ischemic Cardiomyopathy","STB-XTR-003","Inclusion Criteria:\n\n1. Aged 18 to 85 years, regardless of gender.\n2. Diagnosed with ischemic cardiomyopathy (ICM).\n3. significant coronary artery disease (CAD).\n4. Left ventricular systolic dysfunction, with LVEF ranging from \\>20% to ≤40%\n5. Assessed by a team of cardiac surgeons\u002Foperators as suitable for complete revascularization.\n6. Capable of effective communication with the investigators, able to understand and comply with the clinical study requirements, voluntarily participate in the study, and provide written informed consent after being fully informed.\n\nExclusion Criteria:\n\n1. Decompensated heart failure within 48 hours prior to enrollment.\n2. Recent ST-segment elevation myocardial infarction (STEMI) within less than 4 weeks.\n3. Left ventricular aneurysm.\n4. Judged by the investigator as unable to complete PET examination.\n5. Severe renal insufficiency.\n6. Severe hepatic insufficiency.\n7. Subjects with fever or active infectious diseases who are assessed by the investigator as unsuitable for study participation.\n8. Pregnant or lactating women.\n9. Contraindications to magnetic resonance imaging (MRI), such as claustrophobia or intracorporeal metallic implants.\n10. Subjects with mental disorders or poor compliance.\n11. Significant occupational exposure to ionizing radiation (e.g., exceeding 50 mSv per year) or exposure to radioactive substances\u002Fionizing radiation for therapeutic or research purposes within the past 10 years.\n12. Other circumstances deemed by the investigator as unsuitable for trial participation.",{"count":132,"type":20},40,[54],"This is a prospective, multicenter, randomized, open-label, parallel-controlled Phase IIb study to investigate the diagnostic-prognostic utility of XTR003 Injection integrated with 18F-FDG as an exploratory clinical trial. A total of 40-60 patients will be enrolled and randomized into two study groups as: fasting XTR003\u002F18F-FDG group and glucose-loaded group at a 1:1 ratio. Each group will receive resting myocardial perfusion imaging (MPI) combined with metabolic PET imaging to evaluate myocardial metabolic activity and myocardial viability. Segmental perfusion abnormality, metabolic activity and myocardial viability will be analyzed according to the standard approaches in Nuclear Cardiology. Regional and global left ventricular function will be assessed with cardiac MRI and echocardiography prior to and post the completion of full revascularization within 6-month time point. A repeated resting MPI will also be performed to assess the improvement of perfusion abnormality.\n\nAll study subjects will undergo 6 months follow-up for major adverse cardiac events (MACE).",[26,57],[137,138,139,140,141,29],"18F-FDG","XTR003","position emission tomography","myocardial metabolic imaging","myocardial viability","2026-02-26",{"date":144,"type":36},"2026-03-02",{"date":146,"type":36},"2025-12-18",{"date":148,"type":20},"2026-12",{"name":150,"class":71},"Sinotau Pharmaceutical Group",3,{"id":153,"slug":4,"hasResults":10,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":10,"sex":15,"minAge":158,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":163,"conditions":164,"keywords":166,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":181},"100138742","NCT01076660","Left Ventricular Structural Predictors of Sudden Cardiac Death","Left Ventricular Structural Predictors of Sudden Cardiac Death [Substudy of: Functional Energetics and Imaging for Phenotypic Characterization of Patients at Risk for Sudden Cardiac Death, See Also NCT000181233]","Inclusion Criteria:\n\n* LVEF≤35%, referred clinically for ICD insertion for primary prevention purposes (i.e. no prior history of sustained ventricular arrhythmias)\n* Between the ages of 21 and 80 years old\n* Permission of the patient's clinical attending physician\n\nExclusion Criteria:\n\n* Patients who refuse or are unable to give consent.\n* Individuals with contraindications to MRI (i.e. implanted metallic objects such as pre-existing cardiac pacemakers, cerebral clips or indwelling metallic projectiles)\n* Minors.\n* Pregnant women.\n* NYHA Class IV heart failure.\n* Chronic renal insufficiency with creatinine clearance\\\u003C60 ml\u002Fmin; acute renal insufficiency of any severity\n* Claustrophobia\n* Prior adverse reaction to gadolinium-based contrast","21 Years","80 Years",{"count":161,"type":20},400,"OBSERVATIONAL","Sudden cardiac death (SCD) poses a significant health care challenge with high annual incidence and low survival rates. Implantable cardioverter defibrillators (ICDs) prevent SCD in patients with poor heart function. However, the critical survival benefit afforded by the devices is accompanied by short and long-term complications and a high economic burden. Moreover, in using current practice guidelines of reduced heart function, specifically left ventricular ejection fraction (LVEF)≤35%, as the main determining factor for patient selection, only a minority of patients actually benefit from ICD therapy (\\\u003C25% in 5 years). There is an essential need for more robust diagnostic approaches to SCD risk stratification.\n\nThis project examines the hypothesis that structural abnormalities of the heart itself, above and beyond global LV dysfunction, are important predictors of SCD risk since they indicate the presence of the abnormal tissue substrate required for the abnormal electrical circuits and heart rhythms that actually lead to SCD. Information about the heart's structure will be obtained from cardiac magnetic resonance imaging and used in combination with a number of other clinical risk factors to see if certain characteristics can better predict patients at risk for SCD.",[26,165],"Nonischemic Cardiomyopathy",[167,168,169,170,111,171],"Ischemic cardiomyopathy","Nonischemic cardiomyopathy","Implantable cardioverter defibrillator","Sudden Cardiac Death","Ventricular fibrillation","2026-01-15",{"date":174,"type":36},"2026-01-20",{"date":176,"type":4},"2003-10",{"date":178,"type":20},"2030-06",{"name":180,"class":43},"Johns Hopkins University",2,{"id":183,"slug":4,"hasResults":10,"nctId":184,"briefTitle":185,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":21,"phases":189,"briefSummary":190,"conditions":191,"keywords":193,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":44},"100566953","NCT06661876","Cardiac RadiothErapy For hEart faiLure","CREFEL","Inclusion Criteria:\n\n* Patient ≥ 18 years\n* Advanced refractory HF NYHA class II, III or IV\n* Stable HF for the last 6 months with maximal guideline-directed HF therapy\n* Ischemic or dilated cardiomyopathy\n* LVEF at baseline ≤ 35%\n* Ability to give a written informed consent and willingness to return for follow-up\n\nExclusion Criteria:\n\n* Eligible or in consideration for heart transplantation\n* Pregnancy or breastfeeding\n* Previous radiotherapy with cardiac involvement\n* Any condition that is deemed a contraindication in the judgment of the investigators",{"count":132,"type":20},[82],"Preliminary data suggests that patients suffering from advanced refractory heart failure (HF) could benefit from single low dose whole heart external beam radiotherapy (EBRT).\n\nObjective: To explore in our center the efficacy of administering a EBRT treatment of 5Gy to the whole heart in patients with advanced and refractory HF. The hypothesis is that 5Gy EBRT to the whole heart can improve the left ventricular ejection fraction (LVEF) of these patients by a clinically relevant 5%.\n\nMain study endpoints: The primary aim is to explore the efficacy of EBRT treatment for advanced refractory HF. Secondary endpoints include an assessment of safety, overall survival, hospital admissions, late toxicity, quality of life and the effect of the treatment on other heart function indicators (left ventricular volumes, NT-proBNP, Troponine, High sensitive CRP).",[57,192,26],"Non-ischemic Cardiomyopathy",[194,195],"external beam radiotherapy","heart failure","2025-11-28",{"date":198,"type":36},"2025-12-01",{"date":200,"type":36},"2025-01-01",{"date":202,"type":20},"2027-06-30",{"name":204,"class":43},"Universitaire Ziekenhuizen KU Leuven",{"id":206,"slug":4,"hasResults":10,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":44},"100513422","NCT05965258","Phenotypic Classification of FMR With CMR","Improving Phenotypic Classification and Prediction of Treatment Outcomes in Patients With Non-ischemic Cardiomyopathy and Functional Mitral Regurgitation","Inclusion Criteria:\n\n1 CMR LVEF \\\u003C55% 2.FMR Fraction\\>20% or echo criteria consistent with at least moderate mitral regurgitation with adequate image quality\n\nExclusion Criteria:\n\n1. \\>moderate aortic regurgitation\u002Fstenosis,\n2. \\\u003C18 years of age,\n3. acute myocarditis,\n4. eGFR\\\u003C15\n5. HCM\n6. cardiac amyloidosis\u002Fsarcoidosis\n7. prior mitral valve intervention\n8. myocardial infarction within 8 weeks of CMR",{"count":212,"type":20},360,"The goal of the current research is to develop personalized risk prediction for functional mitral regurgitation (FMR) patients through explainable unsupervised phenomapping enriched with advanced cardiac magnetic resonance (CMR) imaging biomarkers, and to determine the CMR predictors of reverse remodeling following modern therapies for FMR.\n\nThe prospective study entails aiming to recruit 360 adult patients (ages \\>18 years) with EF 10-50% and FMR RF\\> 20%, who are clinically referred for CMR evaluation. Patients who enroll in our study will be referred for optimization of mGDMT and will undergo follow-up CMR studies at 6months. NICM patients who are fully medically optimized with significant FMR at the time of the baseline CMR and are referred for Mitraclip treatment will undergo follow-up CMR 6 months from Mitraclip intervention. NICM patients referred for mGDMT optimization, but have persistent or progressive FMR at the time of 6 month follow-up CMR and referred for Mitraclip therapy, will undergo a 2nd follow-up CMR 6 months from Mitraclip therapy.",[215,216,26],"Nonischemic Congestive Cardiomyopathy","Functional Mitral Regurgitation","2025-10-17",{"date":219,"type":36},"2025-10-20",{"date":221,"type":36},"2023-08-29",{"date":223,"type":20},"2028-12-31",{"name":225,"class":43},"The Cleveland Clinic",{"id":227,"slug":4,"hasResults":10,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":21,"phases":235,"briefSummary":236,"conditions":237,"keywords":238,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":251},"100526755","NCT06138873","Ablation-Index Guided Scar-Mediated Ventricular Tachycardia Ablation in Patients With Ischemic Cardiomyopathy","Ablation-Index Guided Scar-Mediated Ventricular Tachycardia Ablation in Patients With Ischemic Cardiomyopathy (AIM-VT) - a Prospective Single-Blinded, Multicenter Randomized Controlled Trial","AIM-VT","Inclusion Criteria:\n\n* Patient ≥ 18 y.o.\n* Structural Heart Disease: Ischemic Cardiomyopathy\n* Sustained Scar-related Monomorphic Ventricular Tachycardia documented by ECG or CIED interrogation\n\nExclusion Criteria:\n\n* If clinical ventricular arrhythmia is predominantly PVCs, supraventricular tachycardia, or ventricular fibrillation\n* Myocardial infarction or cardiac surgery within 6 months\n* Severe mitral regurgitation\n* Stroke or TIA within 6 months\n* Prior VT substrate ablation in the previous 6 months\n* NYHA functional class IV\n* Non-ischemic VT substrate",{"count":234,"type":20},100,[82],"Over the last decade, radiofrequency catheter ablation (RFCA) has become an established treatment for ventricular arrhythmias (VA). Due to the challenging nature of visualizing lesion formation in real time and ensuring an effective transmural lesion, different surrogate measures of lesion quality have been used. The Ablation Index (AI) is a variable incorporating power delivery in its formula and combining it with CF and time in a weighted equation which aims at allowing for a more precise estimation of lesion depth and quality when ablating VAs. AI guidance has previously been shown to improve outcomes in atrial and ventricular ablation in patients with premature ventricular complexes (PVC). However research on outcomes following AI-guidance for VT ablation specifically in patients with structural disease and prior myocardial infarction remains sparse. The investigators aim at conducting the first randomized controlled trial testing for the superiority of an AI-guided approach regarding procedural duration.",[109,26],[239,240,241,29],"ventricular","tachycardia","ablation index","2025-09-17",{"date":244,"type":36},"2025-09-22",{"date":246,"type":36},"2024-10-23",{"date":248,"type":20},"2027-11-23",{"name":250,"class":43},"Rush University Medical Center",5,{"id":253,"slug":4,"hasResults":10,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":159,"enrollmentInfo":259,"targetDuration":4,"studyType":21,"phases":261,"briefSummary":262,"conditions":263,"keywords":269,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":44},"100498344","NCT05769036","Conventional Biventricular Versus Left Bundle Branch Pacing on Outcomes in Heart Failure Patients","Randomized Study of Integrated Evaluation of Conventional Biventricular and Left Bundle Branch Pacing Therapy Effect on Left Ventricular Remodeling and Clinical Outcomes in Patients With Chronic Heart Failure With Reduced Ejection Fraction","RECOVER-HF","Inclusion criteria:\n\n1. The patient is willing and able to comply with the protocol and has provided written informed consent;\n2. Male or female patients aged 18 to 80 years;\n3. Patients with ischemic or non-ischemic cardiomyopathy;\n4. Symptomatic HF for at least 3 months prior to enrollment in the study;\n5. New York Heart Association (NYHA) functional class HF ≥ II;\n6. Patients with HF in sinus rhythm (SR) with LVEF ≤ 35% (measured in the last 6 weeks prior to enrollment), QRS duration ≥150 ms with LBBB morphology;\n7. Patients with HF in SR with LVEF ≤ 35% (measured in the last 6 weeks prior to enrollment), QRS duration 130-149 ms with LBBB morphology;\n8. Patients with HF in SR with LVEF ≤ 35% (measured in the last 6 weeks prior to enrollment), QRS duration ≥150 ms with non-LBBB morphology;\n9. Patients with symptomatic persistent or permanent atrial fibrillation, HF with LVEF \\\u003C 40% (measured in the last 6 weeks prior to enrollment) and an uncontrolled heart rate who are candidates for atrioventricular junction ablation (irrespective of QRS duration);\n10. Patients with HF, LVEF \\\u003C 40% (measured in the last 6 weeks prior to enrollment) and indications for continuous ventricular pacing due to bradycardia;\n11. Patients who have received a conventional pacemaker or an implanted cardioverter-defibrillator and who subsequently develop symptomatic HF with LVEF \\\u003C 40% (measured in the last 6 weeks prior to enrollment) despite optimal medical therapy, and who have a significant proportion of right ventricle pacing;\n12. Optimal HF medical therapy.\n\nExclusion criteria:\n\n1. Coronary artery (CA) bypass grafting, balloon dilatation or CA stenting within 3 months prior to enrollment;\n2. Acute myocardial infarction within 3 months prior to enrollment;\n3. Acute coronary syndrome;\n4. Patients with planned cardiovascular intervention (CA bypass grafting, balloon dilatation or CA stenting);\n5. Patients listed for heart transplant;\n6. Patients with implanted cardiac assist device;\n7. Acute myocarditis;\n8. Infiltrative myocardial disease;\n9. Hypertrophic cardiomyopathy;\n10. Severe primary stenosis or regurgitation of the mitral, tricuspid and aortic valves;\n11. Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age;\n12. Mental or physical inability to participate in the study;\n13. Patients unable or unwilling to cooperate within the study protocol;\n14. Patients with rheumatic heart disease;\n15. Mechanic tricuspid valve patients;\n16. Patients with any serious medical condition that could interfere with this study;\n17. Enrollment in another investigational drug or device study;\n18. Patients not available for follow-up;\n19. Patients with severe chronic kidney disease (estimated glomerular filtration rate ˂ 30 ml\u002Fmin\u002F1.73 m2);\n20. Life expectancy ≤ 12 months;\n21. Participation in another telemonitoring concept.",{"count":260,"type":20},60,[82],"Heart failure (HF) is the most common nosology encountered in clinical practice. Its incidence and prevalence increase exponentially with increasing age and it is associated with increased mortality, more frequent hospitalization and decreased quality of life. An initial approach to the treatment of HF patients with reduced left ventricular (LV) systolic function and left bundle branch block (LBBB) was implantation of cardioresynchronization device using biventricular pacing. This has resulted in long-term clinical benefits such as improved quality of life, increased functional capacity, reduced HF hospitalizations and overall mortality. However, conventional cardiac resynchronization therapy (CRT) is effective in only 70% of patients. And the remaining 30% of patients are non-responders to conventional CRT. Subsequently, His bundle pacing (HBP) has been developed to achieve the same results. According to other studies HBP has showed greater improvement in hemodynamic parameters than with conventional biventricular CRT. But, nevertheless, there are significant clinical troubles with HBP. In this regard, in 2017, the left bundle branch pacing (LBBP) was developed, which demonstrated clinical advantages compared to biventricular CRT. This method has become an alternative to HBP due to the stimulation of LBB outside the blocking site, a stable pacing threshold and a narrow QRS duration. A series of case reports and observational studies have demonstrated the efficacy and safety of LBBP in patients with CRT indications. However, it is not enough data about CRT with LBBP effectiveness in LV remodeling, reducing mortality and complications. According to our hypothesis, CRT with LBBP compared with conventional biventricular CRT will significantly improve the clinical outcomes and reverse LV remodeling in patients with chronic HF with reduced LV ejection fraction and reduce the number of non-responders to conventional CRT.",[57,264,26,265,266,267,268],"Left Bundle-Branch Block","Non-ischemic Dilated Cardiomyopathy","Left Ventricular Dysfunction","Left Ventricular Dyssynchrony","Left Ventricle Remodeling",[270,271,272,273,274],"Cardiac Resynchronization Therapy","Biventricular Pacing","Left Bundle Branch Pacing","Speckle Tracking Echocardiography","Biomarker of Fibrosis and Remodeling","2025-09-03",{"date":277,"type":36},"2025-09-10",{"date":279,"type":36},"2023-10-01",{"date":281,"type":20},"2028-09-01",{"name":283,"class":43},"Tomsk National Research Medical Center of the Russian Academy of Sciences",{"id":285,"slug":4,"hasResults":10,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":21,"phases":293,"briefSummary":294,"conditions":295,"keywords":297,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":307},"100507536","NCT05888662","Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy (EPIC-VT)","Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients Withischemic Cardiomyopathy: a Randomized Controlled Study","EPIC-VT","Inclusion Criteria:\n\n1. Patients over 18 years of age\n2. 1st radiofrequency ablation of VT complicating ischaemic heart disease\n3. Patients with an ICD and remote monitoring\n4. Having, for women of childbearing age, effective contraception until discharge from hospital\n5. Have given their free and informed consent in writing\n6. are affiliated to or have health insurance\n\nExclusion Criteria:\n\n1. History of cardiac surgery compromising the epicardial approach (coronary artery bypass grafting, valve replacements, or other surgeries that may have caused pericardial adhesions)\n2. Presence of a left intraventricular thrombus found during pre-procedure imaging\n3. Anticoagulant therapy that cannot be temporarily discontinued\n4. Double antiplatelet therapy that cannot be temporarily replaced by single antiplatelet therapy\n5. History of pericarditis\n6. Previous thoracic radiotherapy\n7. Contraindication to general anaesthesia\n8. Pregnant or breastfeeding woman\n9. History of heparin-induced thrombocytopenia type 2 (as injection is required during the procedure)\n10. Person under legal protection (safeguard of justice, curatorship, guardianship), deprived of liberty, or unable to express consent",{"count":292,"type":20},150,[82],"Radiofrequency ablation of ventricular tachycardias (VTs) is the gold standard treatment of refractory VTs in patients with ischaemic heart disease. In this setting, ablation is usually performed endocardially. However, even after a procedural success there is a high risk of recurrence, particularly due to the inability to create transmural lesions. Indeed, only the endocardium of the LV has been ablated, while a significant part of the arrhythmia substrate may be located on the other side of the myocardial thickness, on the epicardial side of the LV.\n\nFirst described in 1996, epicardial ablation, performed via a percutaneous subxyphoid approach, has since undergone considerable development. Electrophysiologists often use a double endo- and epicardial approach as first line therapy for the ablation of VTs complicating myocarditis or arrhythmogenic dysplasia of the right ventricle, where the substrate is most often epicardial.\n\nFor VT in ischaemic heart disease, electrophysiologists perform endocardial ablation, and often perform epicardial ablation only after several endocardial failures. Several observational studies suggest that a combined endo- and epicardial approach as first line therapy is associated with a reduced risk of VT recurrence. Since recurrent VT in patients with ischaemic heart disease as a prognostic impact in terms of morbidity and mortality, it appears essential to optimise rhythm management by ablation, by offering a combined approach from the as first approach to reduce the risk of recurrences.\n\nThe aim of our prospective, multicentre, controlled, randomized study is therefore to compare the rate of VT recurrence after ablation performed as first line therapy either by endocardial approach alone or by combined endo-epicardial approach.",[26,296],"Catheter Ablation of Ventricular Tachycardia",[29],"2025-06-23",{"date":300,"type":36},"2025-06-27",{"date":302,"type":36},"2023-10-23",{"date":304,"type":20},"2029-10-23",{"name":306,"class":43},"Rennes University Hospital",12,{"id":309,"slug":4,"hasResults":10,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":10,"sex":15,"minAge":78,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":21,"phases":317,"briefSummary":318,"conditions":319,"keywords":321,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":44},"100502935","NCT05828719","Revascularization Versus Medical Treatment in Patients With Ischemic Left Ventricular Dysfunction","Randomized Controlled Trial of Revascularization Versus Medical Treatment on Clinical Outcomes in Patients With Reduced Left Ventricular Function","RESTORE-PCI","Inclusion Criteria:\n\n* Subject must be at least 19 years of age\n* Patients with stage C heart failure and left ventricular ejection fraction\\\u003C40%\n* Patients with significant coronary artery stenosis (diameter stenosis\\>50% with proven inducible myocardial ischemia by invasive physiologic assessment)\n* Coronary artery disease is amenable for percutaneous coronary intervention (PCI)\n* Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive approach and he\u002Fshe or his\u002Fher legally authorized representative provides written informed consent prior to any study related procedure.\n\nExclusion Criteria:\n\n* Myocardial infarction by universal definition within 4 weeks of randomization\n* Non-viable myocardium in myocardial viability test (cardiac magnetic resonance, dobutamine-stress echocardiography, delayed single-photon emission computerized tomography, or aneurysmal change in echocardiography)\n* Target lesions not amenable for PCI by operators' decision\n* Patients who need left ventricular assisted device (LVAD) or heart transplantation at the time of randomization\n* Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, or Everolimus\n* Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)\n* Pregnancy or breast feeding\n* Non-cardiac co-morbid conditions are present with life expectancy \\\u003C2 year or that may result in protocol non-compliance (per site investigator's medical judgment)\n* Unwillingness or inability to comply with the procedures described in this protocol.",{"count":316,"type":20},900,[82],"Randomized trial to compare clinical outcomes between revascularization versus medical treatment alone in patients with ischemic cardiomyopathy and left ventricular dysfunction.",[320,26],"Heart Failure With Reduced Ejection Fraction",[29,86,322,323],"ejection fraction","guideline-directed medical treatment","2025-03-12",{"date":326,"type":36},"2025-03-14",{"date":328,"type":36},"2023-06-16",{"date":330,"type":20},"2030-12-31",{"name":332,"class":43},"Samsung Medical Center",{"id":334,"slug":4,"hasResults":10,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":340,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":343,"conditions":344,"keywords":353,"overallStatus":357,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":4},"100573590","NCT06748261","AI-enabled Screening and Diagnosis of Cardiomyopathies Using Coronary CTA","Artificial Intelligence-enabled Screening and Diagnosis of Cardiomyopathies Using Coronary Computer Tomography Angiography","Atlantis","Cardiomyopathy cohort:\n\n* Inclusion Criteria:\n\n  1. A clinical diagnosis of cardiomyopathies, including hypertrophic cardiomyopathy, dilated cardiomyopathy, restrictive cardiomyopathy, cardiac amyloidosis, myocarditis, arrhythmogenic right ventricular cardiomyopathy, and coronary artery disease\u002Fischemic heart disease.\n  2. At least one CCTA before surgery or implantable device treatment.\n* Exclusion Criteria:\n\n  1. No recorded diagnosis of cardiomyopathy or undetermined type of cardiomyopathy.\n  2. A clinical diagnosis of secondary cardiac abnormalities due to other organic or systemic diseases.\n  3. Surgery or implantable device treatment before CCTA examination.\n\nControl cohort:\n\n* Inclusion Criteria: participants with at least one CCTA examination.\n* Exclusion Criteria: clinical diagnosis of cardiovascular diseases (including cardiomyopathy, history of myocardial infarction, history of cardiac surgery, stent implantation, ICD implantation and so on) or secondary cardiac abnormalities due to systemic diseases.",true,{"count":342,"type":20},5000,"The goal of this observational and diagnostic study is to develop and validate an artificial intelligence assisted approach for coronary computer tomography angiography-(CCTA)-based screening and diagnosis of cardiomyopathies in patients with suspected coronary artery diseases. This study aims to develop a computerized CCTA interpretation using artificial intelligence for multi-label classification task to assist cardiomyopathy diagnosis in the clinical workflow.",[345,346,347,348,349,26,350,351,352],"Cardiovascular Diseases","Hypertrophic Cardiomyopathy (HCM)","Dilated Cardiomyopathy (DCM)","Restrictive Cardiomyopathy","Amyloid Cardiomyopathy","Arrhythmogenic Right Ventricular Cardiomyopathy","Myocarditis","Cardiomyopathies",[354,352,355,356],"Cardiac computer tomography angiography","Artificial intelligence","Diagnosis","NOT_YET_RECRUITING","2024-12-23",{"date":360,"type":36},"2024-12-27",{"date":362,"type":20},"2024-12-30",{"date":364,"type":20},"2025-12-30",{"name":366,"class":43},"Shanghai Zhongshan Hospital",{"id":368,"slug":4,"hasResults":10,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":372,"eligibilityCriteria":373,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":159,"enrollmentInfo":374,"targetDuration":4,"studyType":21,"phases":375,"briefSummary":376,"conditions":377,"keywords":378,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":388,"locationsCount":44},"100497721","NCT05760924","Left Bundle Branch Pacing on Outcomes and Ventricular Remodeling in Biventricular CRT Nonresponders","Randomized Trial of Left Bundle Branch Pacing Effect on Clinical Outcomes and Left Ventricular Remodeling in Patients With Nonresponse to Biventricular Cardiac Resynchronization Therapy","RESCUE","Inclusion criteria:\n\n1. The patient is willing and able to comply with the protocol and has provided written informed consent;\n2. Male or female patients aged 18 to 80 years;\n3. Patients with ischemic or non-ischemic cardiomyopathy;\n4. Symptomatic HF for at least 3 months prior to enrollment in the study;\n5. New York Heart Association (NYHA) functional class HF ≥ II;\n6. Patients who are non-responders to biventricular CRT with HF, reduced LVEF and CRT-D replacement or one of the CRT-D leads replacement indications (without LVEF increase ≥ 5% and\u002For without a left ventricle end-systolic volume decrease ≥ 15% after CRT-D implantation at least 1 year old);\n7. Optimal HF medical therapy.\n\nExclusion criteria:\n\n1. Coronary artery (CA) bypass grafting, balloon dilatation or CA stenting within 3 months prior to enrollment;\n2. Acute myocardial infarction within 3 months prior to enrollment;\n3. Acute coronary syndrome;\n4. Patients with planned cardiovascular intervention (CA bypass grafting, balloon dilatation or CA stenting);\n5. Patients listed for heart transplant;\n6. Patients with implanted cardiac assist device;\n7. Acute myocarditis;\n8. Infiltrative myocardial disease;\n9. Hypertrophic cardiomyopathy;\n10. Severe primary stenosis or regurgitation of the mitral, tricuspid and aortic valves;\n11. Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age;\n12. Mental or physical inability to participate in the study;\n13. Patients unable or unwilling to cooperate within the study protocol;\n14. Patients with rheumatic heart disease;\n15. Mechanic tricuspid valve patients;\n16. Patients with any serious medical condition that could interfere with this study;\n17. Enrollment in another investigational drug or device study;\n18. Patients not available for follow-up;\n19. Patients with severe chronic kidney disease (estimated glomerular filtration rate ˂ 30 ml\u002Fmin\u002F1.73 m2);\n20. Life expectancy ≤ 12 months;\n21. Participation in another telemonitoring concept.",{"count":19,"type":20},[82],"Heart failure (HF) is the most common nosology encountered in clinical practice. Its incidence and prevalence increase exponentially with increasing age and it is associated with the increased mortality, more frequent hospitalization and decreased quality of life. An initial approach to the treatment of HF patients with reduced left ventricular (LV) systolic function and left bundle branch block (LBBB) was implantation of device for cardiac resynchronization therapy using biventricular pacing. This has resulted in long-term clinical benefits such as improved quality of life, increased functional capacity, reduced HF hospitalizations and overall mortality. However, conventional cardiac resynchronization therapy (CRT) is effective in only 70% of patients. And the remaining 30% of patients are non-responders to conventional CRT. Cardiac conduction system pacing is currently a promising technique for these patients. Particularly, His bundle pacing (HBP) has been developed to achieve the same results. According to other studies HBP has shown greater improvement in hemodynamic parameters comparing with conventional biventricular CRT. But, nevertheless, there are significant clinical troubles with HBP, especially high pacing threshold. In this regard, in 2017, the left bundle branch pacing (LBBP) was developed, which demonstrated clinical advantages compared to conventional biventricular CRT. Also, since 2019, left bundle branch pacing-optimized CRT (LBBPO CRT) has been used in clinical practice. These methods have become an alternative to HBP due to the stimulation of LBB outside the blocking site, a stable pacing threshold and a narrow QRS complex duration on electrocardiogram. A series of case reports and observational studies have demonstrated the efficacy and safety of LBBP and LBBPO CRT in patients with CRT indications. However, it is not enough data about impact of CRT with LBBP and combined CRT with LBBP and LV pacing on myocardial remodeling, reducing mortality and complications. According to our hypothesis, CRT with LBBP and combined CRT with LBBP and LV pacing compared with conventional biventricular pacing will significantly improve the clinical outcomes and reverse myocardial remodeling in patients who are non-responders to biventricular CRT with HF, reduced LV ejection fraction and with indications to CRT devices with defibrillator function (CRT-D) or one of the CRT-D leads replacement.",[57,264,26,265,266,268],[270,271,272,273,274,379,380,381],"Combined Left Bundle Branch and Left Ventricular Pacing","CRT Non-responder","CRT Responder","2024-11-20",{"date":384,"type":36},"2024-11-22",{"date":386,"type":36},"2024-11-01",{"date":281,"type":20},{"name":283,"class":43},{"id":390,"slug":4,"hasResults":10,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":396,"targetDuration":4,"studyType":21,"phases":398,"briefSummary":399,"conditions":400,"keywords":407,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":44},"100487848","NCT05632432","Atrial Appendage Micrograft Transplants to Assist Heart Repair After Cardiac Surgery","Autologous Atrial Appendage Micrografts Transplanted During Coronary Artery Bypass Surgery: the AAMS2 Randomized, Double-blinded, and Placebo-controlled Trial","AAMS2","Inclusion Criteria:\n\n* Informed consent obtained\n* Left ventricular ejection fraction (LVEF) between ≥ 15% and ≤ 40% at recruitment (transthoracic echocardiography)\n* New York Heart Association (NYHA) Class II-IV heart failure symptoms\n\nExclusion Criteria:\n\n* Heart failure due to left ventricular outflow tract obstruction\n* Acute myocardial infarction (AMI) within last 30 days\n* History of life-threatening and possibly repeating ventricular arrhythmias or resuscitation, or an implantable cardioverter-defibrillator\n* Stroke or other disabling condition within 3 months before screening\n* Severe valve disease or scheduled valve surgery\n* Renal dysfunction (GFR \\\u003C45 ml\u002Fmin\u002F1.73m2)\n* Other disease limiting life expectancy\n* Contraindications for coronary angiogram or LGE-CMRI\n* Participation in some other clinical trial\n\nScreening Failure:\n\n* After optimization of medications, no visible scar or LVEF ≥ 50% in preoperative LGE-CMRI\n* Preoperative LGE-CMRI has not been performed prior scheduled CABG",{"count":397,"type":20},50,[82],"Ischemic heart disease (IHD) leads the global mortality statistics. Atherosclerotic plaques in coronary arteries hallmark IHD, drive hypoxia, and may rupture to result in myocardial infarction (MI) and death of contractile cardiac muscle, which is eventually replaced by a scar. Depending on the extent of the damage, dysbalanced cardiac workload often leads to emergence of heart failure (HF).\n\nThe atrial appendages, enriched with active endocrine and paracrine cardiac cells, has been characterized to contain cells promising in stimulating cardiac regenerative healing.\n\nIn this AAMS2 randomized controlled and double-blinded trial, the patient's own tissue from the right atrial appendage (RAA) is for therapy. A piece from the RAA can be safely harvested upon the set-up of the heart and lung machine at the beginning of coronary artery bypass (CABG) surgery. In the AAMS2 trial, a piece of the RAA tissue is processed and utilized as epicardially transplanted atrial appendage micrografts (AAMs) for CABG-support therapy.\n\nIn our preclinical evaluation, epicardial AAMs transplantation after MI attenuated scarring and improved cardiac function. Proteomics suggested an AAMs-induced glycolytic metabolism, a process associated with an increased regenerative capacity of myocardium. Recently, the safety and feasibility of AAMs therapy was demonstrated in an open-label clinical study. Moreover, as this study suggested increased thickness of the viable myocardium in the scarred area, it also provided the first indication of therapeutic benefit.\n\nBased on randomization with estimated enrolment of a total of 50 patients with 1:1 group allocation ratio, the piece of RAA tissue is either perioperatively processed to AAMs or cryostored. The AAMs, embedded in a fibrin matrix gel, are placed on a collaged-based matrix sheet, which is then epicardially sutured in place at the end of CABG surgery. The location is determined by preoperative late gadolinium enhancement cardiac magnetic resonance imaging (LGE-CMRI) to pinpoint the ischemic scar. The controls receive the collagen-based patch, but without the AAMs. Study blood samples, transthoracic echocardiography (TTE), and LGE-CMRI are performed before and at 6-month follow-up after the surgery.\n\nThe trial's primary endpoints focus on changes in cardiac fibrosis as evaluated by LGE-CMRI and circulating levels of N-terminal prohormone of brain natriuretic peptide (NT-proBNP). Secondary endpoints center on other efficacy parameters, as well as both safety and feasibility of the therapy.",[401,26,402,403,404,405,406],"Ischemic Heart Disease","Heart Failure, Systolic","Heart Failure NYHA Class III","Heart Failure NYHA Class II","Heart Failure NYHA Class IV","Coronary Artery Disease",[408,409,410,411,412,413,167,414,415,27,416],"Ischemic heart failure","Ischemic heart disease","Coronary artery disease","Coronary artery bypass grafting","Atrial appendage micrografts","Tissue-engineering","Atrial appendage","Micrografts","Epitranscriptomics","2024-04-18",{"date":419,"type":36},"2024-04-19",{"date":421,"type":36},"2024-04-01",{"date":423,"type":20},"2026-12-31",{"name":425,"class":43},"Hospital District of Helsinki and Uusimaa",{"id":427,"slug":4,"hasResults":10,"nctId":428,"briefTitle":429,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":10,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":431,"targetDuration":433,"studyType":162,"phases":4,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":443,"locationsCount":44},"100209121","NCT01999140","Implantable Cardioverter Defibrillator (ICD Registry)","All U.S and International patients.\n\nInclusion Criteria:\n\n* All patients who receive an ICD\u002FCRT-D (initial or generator change) for primary or secondary prevention purposes.\n* All patients with an ICD\u002FCRT-D undergoing a Lead Only procedure.\n* U.S. populations must submit all patients who receive an ICD\u002FCRT-D (initial or generator change) for primary prevention purposes who are insured by Medicare.\n\nExclusion Criteria:\n\nNone",{"count":432,"type":20},1750,"1 Day","The ICD Registry™ is a nationwide quality program that helps participating hospitals measure and improve care for patients receiving implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices with defibrillator (CRT-Ds). The ICD Registry captures the characteristics, treatments, and outcomes of patients receiving (ICDs). Patient-level data is submitted by participating hospitals on a quarterly basis to the American College of Cardiology Foundation's (ACCF) National Cardiovascular Data Registry (NCDR) which then produces an Outcomes Report of the hospital's data, with comparison to both a volume peer group (number of ICD patients submitted annually) and the entire ICD registry data set.",[57,165,26,436,437],"Ventricular Arrhythmia","Complications; Device, Cardiac","2024-04-17",{"date":417,"type":36},{"date":441,"type":4},"2005-06",{"date":178,"type":20},{"name":444,"class":43},"American College of Cardiology",""]