RecruitingNot Applicable

Primary Preventive Ventricular Tachycardia Ablation In High-Risk Patients Who Receive A Prophylactic Implantable Cardioverter Defibrillator

France, Spain62 participantsStarted 2026-01-22

Plain-language summary

This prospective, multicenter, open-label, randomized-controlled trial compares two treatment strategies in high-risk ischemic cardiomyopathy (ICM) patients referred for primary ICD implantation. Participants will be randomized to receive either prophylactic VT ablation within three months of ICD implantation or continued medical management. The primary objective is to assess the efficacy of preventive VT ablation versus medical management in reducing VT arrhythmia burden.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 18 years (no upper age limit) * Willing and able to provide informed consent * Candidate for a primary prevention ICD/CRT-D per ESC guidelines17 * Ischemic cardiomyopathy (ICM) with left ventricular ejection fraction (LVEF) ≤ 35% * Willing and able to receive an ICD * Willing and able to undergo catheter-based VT ablation One or more of the following: * MADIT-ICD Benefit Score \>75 * History of nonsustained ventricular tachycardia (NSVT) * Multiple premature ventricular complexes (PVCs ≥10%) Exclusion Criteria: * Existing ICD or CRT-D * History of sustained VT or VF * Chronic renal failure requiring hemodialysis * Coronary revascularization within the past 3 months * ST-Elevation MI within the past 3 months * Participation in concurrent clinical trials without approval from the Coordination Center (observational registries are allowed with approval) * Currently pregnant or planning to become pregnant in the near future * Inability or unwillingness to adhere to the study protocol * Inability or unwillingness to provide informed consent for participation * Life expectancy \< 1 year

What they're measuring

Total Number of VT Arrhythmia Events in High-Risk Patients with Ischemic Cardiomyopathy (ICM) After Primary ICD Implantation: Comparison of Preventive Catheter-Based VT Ablation Versus Medical Management.

Timeframe: One year following ICD implantation.

Trial details

NCT IDNCT06543173

SponsorUniversity of Rochester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-08-01

Contact for this trial

Ilan Goldenberg, MD

585-275-5391 Ilan_Goldenberg@URMC.Rochester.edu