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Clinical trial Recruiting at 5 sites Interventional Ages 18 and up

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

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

Run by University of Rochester · NCT06543173 · Data updated 2026-11-12

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.

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Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment62 (estimated)
SponsorUniversity of Rochester
Academic / other
Locations5 sites (Copenhagen, Region H and 4 other locations)
StatusRecruiting
StartedJanuary 22, 2026
Main results expectedAugust 1, 2030
Study endsAugust 1, 2030
Registry record updatedMay 19, 2026
Trial IDNCT06543173 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • Righospitalet
    Copenhagen, Region H, Denmark     Recruiting
  • Centre Hospitalier De Pau
    Pau, Gave de Pau, France     Recruiting
  • Hopital Trousseau Chru de Tours
    Chambray-lès-Tours, Indre-et-Loire, France     Recruiting
  • Centre Hospitalier Universitaire de Bordeaux
    Pessac, France     Recruiting
  • Unidad de Arritimias, Hospital Clínic Barcelona
    Barcelona, Spain     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.