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

RecruitingNAAges 18 Years - anyAllUniversity of Rochester
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Prophylactic Catheter-based VT Ablation
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Where

5 sites
Righospitalet
Copenhagen, Denmark
Centre Hospitalier De Pau
Pau, France
Hopital Trousseau Chru de Tours
Chambray-lès-Tours, France
Centre Hospitalier Universitaire de Bordeaux
Pessac, France
Unidad de Arritimias, Hospital Clínic Barcelona
Barcelona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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