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Taking people in DenmarkNo phase

Tests a heart procedure to prevent dangerous fast heartbeats in heart failure

Tests catheter ablation before a defibrillator in adults with ischemic heart failure.

Plain-language title generated from the registry record
Registry title: Primary Preventive Ventricular Tachycardia Ablation In High-Risk Patients Who Receive A Prophylactic Implantable Cardioverter Defibrillator

Key facts

Where
Copenhagen, DenmarkSee the site

Where in Denmark

  • RighospitaletCopenhagen, DenmarkTaking people

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Trial details

Who runs it
University of Rochester
Trial code
NCT06543173
Record updated
19 May 2026
Original description
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.Read full original descriptionShow less

Primary Preventive Ventricular Tachycardia Ablation In High-Risk Patients Who Receive A Prophylactic Implantable Cardioverter Defibrillator (PRIMARY PREVENT-VT TRIAL)

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.

Inclusion: 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: Participation in concurrent clinical trials without approval from the Coordination Center (observational registries are allowed with approval); History of sustained VT or VF; Chronic renal failure requiring hemodialysis; Existing ICD or CRT-D; Coronary revascularization within the past 3 months; ST-Elevation MI within the past 3 months; 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.

ClinicalTrials.gov NCT06543173