Preventive ventricular tachycardia ablation for high-risk patients receiving a primary ICD

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

This will test whether doing catheter-based preventive VT ablation within three months of getting a primary ICD reduces ventricular tachycardia events in people with ischemic cardiomyopathy and low ejection fraction.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Rochester (Academic / other)
• Locations: 2 sites (Pessac and 1 other locations)
• Trial ID: NCT06543173 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, open-label, randomized trial that will enroll about 62 high-risk ischemic cardiomyopathy patients referred for primary ICD implantation and randomize them 1:1. One group will receive prophylactic catheter-based VT ablation using high-density electroanatomic mapping (Ensite) within three months of ICD placement, and the other group will continue standard medical management. The primary outcome is VT arrhythmia burden, defined as the total number of VT events detected by the ICD one year after implantation. The trial is conducted across roughly 20 experienced European sites with centralized follow-up.

Who should consider this trial

Good fit: Ideal candidates are adults with ischemic cardiomyopathy and LVEF ≤35% who are candidates for a primary prevention ICD and have high-risk features (for example, MADIT-ICD benefit score >75, prior nonsustained VT, or frequent PVCs) and are willing to undergo catheter ablation.

Not a fit: Patients with an existing ICD/CRT-D, prior sustained VT or VF, recent MI or recent coronary revascularization, chronic dialysis-dependent renal failure, inability to undergo ablation, or pregnancy are unlikely to receive benefit from the preventive ablation strategy.

Why it matters

Potential benefit: If successful, the approach could substantially reduce VT episodes and ICD therapies, potentially lowering shocks, hospital admissions, and improving quality of life.

How similar studies have performed: Ablation has demonstrable benefit in patients with recurrent or secondary-prevention VT, but using prophylactic ablation at the time of primary ICD implantation is relatively novel and not yet widely proven.

Eligibility criteria

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

Where this trial is running

Pessac and 1 other locations

• Centre Hospitalier Universitaire de Bordeaux — Pessac, France (Recruiting)
• Unidad de Arritimias, Hospital Clínic Barcelona — Barcelona, Spain (Recruiting)

Study contacts

• Study coordinator: Ilan Goldenberg, MD

Conditions Heart Failure