[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Imricor Medical Systems\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100508755",false,"NCT05904548","Atrial Flutter Ablation in the iCMR","Vision-MR Ablation Catheter 2.0 for Treatment of Type I Atrial Flutter","VISABL-AFL","Inclusion Criteria:\n\n* Patient indicated for type I atrial flutter ablations with at least 1 documented episode of type I atrial flutter within 6 months (180 days) of enrollment\n* Patient 18 years and older\n\nExclusion Criteria:\n\n* Contraindications for MRI procedures\n* Patients who cannot have anti-arrhythmic drugs (class I or class III) prescribed for the treatment of type I atrial flutter stopped on the day of the procedure\n* Previous CTI ablation procedures\n* Myocardial infarction within 60 days of enrollment\n* Current unstable angina\n* Cardiac surgery within 90 days of enrollment\n* Any cerebral ischemic event (including transient ischemic attacks) within 6 months (180 days) of enrollment\n* Thrombocytosis or thrombocytopenia\n* Contraindication to anticoagulation therapy\n* Currently documented intracardiac thrombus or myxoma\n* Implantation of permanent leads of an implantable device in or through the right atrium within 90 days of enrollment\n* Prosthetic valve through which the catheter must pass\n* Interatrial baffle or patch through which the catheter must pass\n* Moderate or severe tricuspid valve regurgitation or stenosis\n* Uncompensated congestive heart failure\n* Active systemic infection\n* Pregnancy or if subject plans to become pregnant during the trial\n* Uncontrolled hyperthyroidism\n* Any other significant uncontrolled or unstable medical condition\n* Enrollment in any concurrent study without Imricor written approval\n* Life expectancy of less than or equal to 2 years (730 days) per physician opinion","ALL","18 Years",{"count":19,"type":20},91,"ESTIMATED","INTERVENTIONAL",[23],"NA","The VISABL-AFL clinical investigation is a prospective, single-arm, multi-center, interventional, Investigational Device Exemption (IDE) trial. The primary objectives of VISABL-AFL are to assess the safety and efficacy of radiofrequency (RF) ablation of type-I atrial flutter performed with the Vision-MR Ablation Catheter 2.0 in the iCMR environment.",[26],"Atrial Flutter Typical",[28,29],"RF Ablation","interventional Cardiac Magnetic Resonance (iCMR)","RECRUITING","2026-04-08",{"date":33,"type":34},"2026-04-13","ACTUAL",{"date":36,"type":34},"2024-06-20",{"date":38,"type":20},"2026-12-31",{"name":40,"class":41},"Imricor Medical Systems","INDUSTRY",6,{"id":44,"slug":4,"hasResults":10,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100481038","NCT05543798","VT Ablation in the iCMR","Vision-MR Ablation Catheter 2.0 for the Treatment of Ventricular Tachycardia","VISABL-VT","Inclusion Criteria:\n\n* Roll-in subjects only: Documentation of premature ventricular contractions indicated for ablation therapy (subjects may or may not be diagnosed with Ischemic Cardiomyopathy)\n* Documented (ECG\u002FEGM) spontaneous episode of sustained ventricular tachycardia within 6 months of the procedure\n* Diagnosis of Ischemic Cardiomyopathy\n* AAD therapy refractory, contraindicated, not tolerated, or not desired\n* 18 years or older\n\nExclusion Criteria:\n\n* Implanted with non-MR compatible medical devices or contraindicated for an MRI\n* Presence of intracardiac thrombus (verified via CT\u002FMRI\u002FTEE\u002FTTE within 48 hours of procedure - or at start of procedure)\n* Thrombocytopenia or coagulopathy\n* Mechanical mitral and\u002For aortic valve precluding access to the left ventricle\n* Severe aortic stenosis\n* Myocardial infarction requiring stent implantation within 90 days of procedure\n* Previous cardiac surgery within 60 days of procedures\n* Known\u002Funcontrolled stroke risks\n* Class IV Heart Failure\n* Ejection Fraction (EF) \\\u003C 25%\n* Patients with a glomerular filtration rate (GFR) \\\u003C 30\n* Women who are pregnant\n* Allergy to contrast agents (e.g., Gadolinium)\n* Active infection\n* Known or suspected myxoma\n* Unstable angina\n* Patients who do not tolerate anticoagulation therapy\n* Previous intertribal septal patch or prosthetic atrial septal defect closure device\n* Life expectancy \\\u003C 12 months\n* Enrollment in another study without sponsor approval",{"count":51,"type":20},64,[23],"The VISABL-VT is a prospective, single-arm, multi-center, interventional investigation of the safety and efficacy of radiofrequency (RF) ablation of ventricular tachycardia associated with ischemic cardiomyopathy performed with the Vision-MR Ablation Catheter 2.0 in the iCMR environment.",[55],"Ventricular Tachycardia","2026-01-06",{"date":58,"type":34},"2026-01-08",{"date":60,"type":34},"2025-04-10",{"date":62,"type":20},"2027-06",{"name":40,"class":41},3,""]