[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Endotronix, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100511057",false,"NCT05934487","PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III","A Prospective, Multi-Center, Open Label, Randomized Control Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class II-III Heart Failure Patients","Inclusion Criteria 1. Subject has given written informed consent 2. Male or female, at least 18 years of age 3. Diagnosis and treatment of HF (regardless of LVEF) for ≥ 3 months and NYHA Class II HF (NYHA II Cohort) or NYHA III (NYHA III Cohort) at time of Screening\n\n4\\. Subjects should be receiving appropriate medical therapy for heart failure according to current AHA\u002FACC guidelines as standard-of-care for HF therapy in the United States, or current ESC guidelines for HF treatment in Europe for at least 30 days prior to the Screening\u002FEnrollment visit. Stable is defined as no more than a 100% increase or 50% decrease in dose. These criteria may be waived if a subject is intolerant of ACE-I, ARB, ARNI), MRA, beta-blockers, or SGLT2i, subject is unable to afford these agents, subject has contraindications to these agents, or these agents are not indicated under the Guidelines. Such intolerance, lack of affordability, contraindications, or lack of indications must be documented.\n\n1. HFrEF (EF \\\u003C 50%): Subject has been on stable medications maximized to the subject's tolerance of ACE-I or ARB or ARNI, MRA, beta-blockers, and SGLT2i as determined by the study investigator for at least 30 days prior to Screening\u002FEnrollment\n2. HFpEF (EF ≥ 50%): Subject has been on stable medication maximized to the subject's tolerance of SGLT2i as determined by the study investigator for at least 30 days prior to Screening\u002FEnrollment 5. NYHA II Cohort- HF related hospitalization within 6 months (last hospitalization should be 30 days before Screening \u002FEnrollment) 5. NYHA III Cohort -HF related hospitalization within 12 month (last hospitalization should be 30 days before Screening\u002FEnrollment)\n\n   6\\. Subjects should be on diuretic therapy (≥40 mg\\] furosemide or equivalent) for ≥ 1 month at time of Screening\n\n   7\\. Subjects who are physically able to hold the myCordella™ Patient Reader unit (approximate weight 1.3lb) against the ventral thoracic surface for up to 2 minutes per day while in a seated position, as well as dock and undock the myCordella™ Patient Reader\n\n   8\\. Subjects with sufficient eyesight, hearing, and mental capacity to respond to the myCordella™ Patient Reader's audio\u002Fvisual cues and operate the myCordella™ Patient Reader\n\n   9\\. Subject has sufficient Cellular and\u002F or Wi- Fi Internet coverage at home\n\n   10\\. Subject agrees to return to the treating Investigator for all scheduled follow up visits and can return to the hospital for follow up\n\n   Exclusion Criteria:\n   1. ACC\u002FAHA Stage D refractory HF (including a known history of \\>24 hours of IV inotropic therapy to support circulation within the past 6 months (other than relation to a procedure))\n   2. Subjects with history of recurrent pulmonary embolism (≥2 episodes within 5 years prior to Screening Visit) and\u002For deep vein thrombosis in the femoral or IJ vein used for access (\\\u003C 3 month prior to Screening Visit)\n   3. Subjects with a resting systolic blood pressure \\\u003C90 mmHg and\u002F or severe pre-capillary pulmonary hypertension with a pulmonary artery systolic pressure of ≥70 mm\u002FHg with pulmonary capillary wedge pressure ≤ 15 mmHg at the Cordella PA Sensor Implant RHC (V2)\n   4. Subjects who have had a major cardiovascular (CV) event (e.g., myocardial infarction, stroke) within 3 months of the Screening Visit\n   5. Unrepaired severe valvular disease\n   6. Subjects with significant congenital heart disease that has not been repaired and would prevent implantation of the Cordella PA Sensor or mechanical\u002Ftissue right heart valve(s)\n   7. Subjects with known coagulation disorders\n   8. Subjects with a hypersensitivity or allergy to platelet aggregation inhibitors including aspirin, clopidogrel, prasugrel, and ticagrelor; or patients unable to take dual antiplatelet or anticoagulants for one-month post implant\n   9. Known history of life-threatening allergy to contrast dye.\n   10. Subjects whereby RHC is contraindicated\n   11. Subjects with an active infection at the Cordella Sensor Implant Visit\n   12. Subjects with a GFR \\\u003C20 ml\u002Fmin or who are on chronic renal dialysis\n   13. Implanted with Cardiac Resynchronization Therapy-Pacemaker (CRT-P) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D), or having undergone mitral\u002Ftricuspid valve repair\u002Freplacement within 90 days or catheter ablation for atrial fibrillation within 30 days prior to screening visit\n   14. Received or are likely to receive an advanced therapy (e.g., durable mechanical circulatory support or lung or heart transplant) in the next 24 months\n   15. Subjects who are pregnant or breastfeeding\n   16. Subjects who are unwilling or deemed by the Investigator to be unwilling to comply with the study protocol, or subjects with a history of non-compliance\n   17. Severe illness, other than heart disease, which would limit survival to \\\u003C2 years\n   18. Subjects whose clinical condition, in the opinion of the Investigator, makes them an unsuitable candidate for the study\n   19. Subjects enrolled in another investigational trial with an active Treatment Arm\n   20. Subject who is in custody by order of an authority or a court of law","ALL","18 Years",{"count":18,"type":19},1750,"ESTIMATED","INTERVENTIONAL",[22],"NA","This is a prospective, multi-center, open label, randomized control clinical trial evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2 Trial).\n\nThe study contains of 5 arms:\n\nNYHA II Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class II HF patients, where patients have daily access to PAP data.\n\n* Treatment Arm (Group 1)\n* Active Control Arm (Group 2)\n* Crossover Arm (Group 3)\n\nNYHA III Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class III HF patients, where patients have daily access to PAP data, including a randomized sub-study to evaluate a clinician-directed patient self-management strategy.",[25,26,27],"Heart Failure NYHA Class II","Heart Failure NYHA Class III","Heart Failure",[27,29,30,31],"Heart Disease","Cardiovascular Disease","Pulmonary Artery Pressure","RECRUITING","2026-06-25",{"date":35,"type":36},"2026-06-29","ACTUAL",{"date":38,"type":36},"2023-11-29",{"date":40,"type":19},"2033-09",{"name":42,"class":43},"Endotronix, Inc.","INDUSTRY",48,{"id":46,"slug":4,"hasResults":10,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100576287","NCT06783335","Real World Effectiveness of the Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Heart Failure","The Real-World Effectiveness of The Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Failure: A Comparative Analysis to Standard of Care Pharmacologic Therapy","LOWER-PAP","Inclusion Criteria for Cordella PA Sensor System Cohort:\n\n* Received Cordella PA Sensor System implant between 10\u002F1\u002F2024-12\u002F31\u002F2029\n* Documented chronic heart failure with NYHA Class III symptoms\n* On guideline-directed medical therapy based on ejection fraction status:\n\n  * For reduced EF (≤40%): At least one fill of ACE\u002FARB\u002FARNI, MRA, BB, or SGLT2i, and one fill of a loop diuretic\n  * For preserved EF (\\>40%): At least one fill of a loop diuretic\n* Has continuous health insurance enrollment for 12 months prior to implant\n\nInclusion Criteria for Standard of Care Control Cohort:\n\n* Two or more encounters with diagnosis codes for chronic systolic and\u002For diastolic heart failure\n* Documented ejection fraction reading within 6 months (+ or -) of second heart failure encounter\n* On guideline-directed medical therapy based on ejection fraction status:\n\n  * For reduced EF (≤40%): At least one fill of ACE\u002FARB\u002FARNI, MRA, BB, or SGLT2i, and one fill of a loop diuretic\n  * For preserved EF (\\>40%): At least one fill of a loop diuretic\n* Has continuous health insurance enrollment for 12 months prior to study entry\n\nExclusion Criteria:\n\n* No implanted pulmonary artery sensor or monitoring at any time (Standard of Care Control Cohort only)\n* Record of temporary mechanical circulatory support during baseline period\n* Diagnosis of cardiogenic shock during baseline period\n* Receiving palliative care\u002Fhospice during baseline period\n* Record of end-stage renal disease during baseline period\n* Unable to take dual antiplatelet therapy or anticoagulants for one month post implant (Cordella Cohort only)",{"count":53,"type":19},2150,"OBSERVATIONAL","This retrospective, non-randomized cohort study will evaluate how well the Cordella PA Sensor System works compared to standard medication treatment in people with chronic heart failure. The study will track patients for two years to see if those using the Cordella system have fewer deaths and hospitalizations related to heart failure.",[26,27],[58,29,59,30,60],"Heart failure","Pulmonary Artery Pressure Sensor","Cordella","2025-11-18",{"date":63,"type":36},"2025-11-19",{"date":65,"type":36},"2025-02-07",{"date":67,"type":19},"2030-12-31",{"name":42,"class":43},1,""]