NCT06543173Recruiting
Primary Preventive Ventricular Tachycardia Ablation In High-Risk Patients Who Receive A Prophylactic Implantable Cardioverter Defibrillator
Primary Preventive Ventricular Tachycardia Ablation In High-Risk Patients Who Receive A Prophylactic Implantable Cardioverter Defibrillator (PRIMARY PREVENT-VT TRIAL)
Source: ClinicalTrials.gov · Last updated 19 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 62 (estimated)
- First submitted
- 17 Jun 2024
- Start date
- 22 Jan 2026
- Primary completion date
- 1 Aug 2030
- Lead sponsor
- University of Rochester
- Diseases
- Heart failure
- NCT number
- NCT06543173
What you commit to
- Study type: Interventional
- Planned participants: 62
- From 22 Jan 2026 to the primary completion date, 1 Aug 2030
- 5 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in concurrent clinical trials without approval from the Coordination Center (observational registries are allowed with approval)
Other illness
- History of sustained VT or VF
- Chronic renal failure requiring hemodialysis
Other
- 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
Who the study is looking for
- 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%)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Righospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
| Unidad de Arritimias, Hospital Clínic Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hopital Trousseau Chru de Tours Coordinator of this site? Confirm its status | Chambray-lès-Tours | France | Recruiting |
| Centre Hospitalier de Pau Coordinator of this site? Confirm its status | Pau | France | Recruiting |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.