Tests a heart procedure to prevent dangerous fast heartbeats in heart failure
Tests catheter ablation before a defibrillator in adults with ischemic heart failure.
Key facts
- Who runs it
- University of Rochester
- Where
- Barcelona, SpainSee the siteAlso in 2 other countries, 4 sites
- Trial code
- Registry title
- Primary Preventive Ventricular Tachycardia Ablation In High-Risk Patients Who Receive A Prophylactic Implantable Cardioverter Defibrillator
- Status
- Recruiting
- People taking part
- 62 people, planned
- Started
- 22 Jan 2026
- Expected to end
- 1 Aug 2030
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Prophylactic Catheter-based VT Ablation
- Record updated
- 19 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with heart failure from ischemic cardiomyopathy who are due to get a preventive ICD. It compares a catheter ablation for fast heart rhythms with medicines alone.
- Age
- 18 years or older, no upper age limit.
- Sex
- All sexes can join.
- Disease stage
- Ischemic cardiomyopathy with left ventricular ejection fraction (LVEF) of 35% or lower, and a candidate for a preventive ICD/CRT-D by ESC guidelines. They also need one or more of: MADIT-ICD Benefit Score above 75, past nonsustained ventricular tachycardia (NSVT), or PVCs of 10% or more.
- Earlier treatment
- Cannot already have an ICD or CRT-D. Cannot have had coronary revascularization or an ST-elevation heart attack in the past 3 months.
Main reasons for not taking part
- Already has an ICD or CRT-D
- History of sustained VT or VF
- Chronic kidney failure needing hemodialysis
- Heart attack (ST-elevation) or coronary revascularization in the past 3 months
- Currently pregnant or planning pregnancy soon
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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%)
Who cannot take part
- 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
Where in Spain
Also in 2 other countries, 4 sites
- Unidad de Arritimias, Hospital Clínic BarcelonaBarcelona, SpainContact: Ivo Roca Luque, MDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Prophylactic Catheter-based VT AblationTreatment being tested
Subjects receive catheter-based ventricular tachycardia (VT) ablation within 3 months of primary ICD implantation.
- Continued Medical ManagementNo study treatment, for comparison
Subjects undergo continued medical management after primary ICD implantation without prophylactic VT ablation.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Primary Preventive Ventricular Tachycardia Ablation In High-Risk Patients Who Receive A Prophylactic Implantable Cardioverter Defibrillator (PRIMARY PREVENT-VT TRIAL)
- Plain-language title
- Tests a heart procedure to prevent dangerous fast heartbeats in heart failureGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 19 May 2026