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

May 14, 2026 updated by: Ilan Goldenberg, University of Rochester

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to assess the impact of prophylactic catheter-based ventricular tachycardia (VT) ablation compared to medical management in high-risk patients with ischemic cardiomyopathy (ICM) undergoing primary implantable cardioverter defibrillator (ICD) implantation. The primary outcome measure is the burden of VT arrhythmias (VTA), defined as the total number of VT events, one year post-ICD implantation. The hypothesis suggests that employing VT ablation with high-density electroanatomic mapping (EnsiteTM) will significantly reduce both treated and monitored VT episodes. The study will randomize 62 participants in a 1:1 ratio across 20 experienced sites in Europe.

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
  • France
      • Pessac, France
        • Recruiting
        • Centre Hospitalier Universitaire de Bordeaux
        • Principal Investigator:
          • Frédéric Sacher, MD
        • Contact:
        • Contact:
          • Fabrice Blard
          • Phone Number: Poste 52074 05.25.35.20.74
    • Gave de Pau
      • Pau, Gave de Pau, France, 64000
        • Recruiting
        • Centre Hospitalier de Pau
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maxime De Guillebon, MD
    • Indre-et-Loire
      • Chambray-lès-Tours, Indre-et-Loire, France, 37170
        • Recruiting
        • Hopital Trousseau Chru de Tours
        • Principal Investigator:
          • Bertrand Pierre, MD
        • Contact:
        • Contact:
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Unidad de Arritimias, Hospital Clínic Barcelona
        • Principal Investigator:
          • Ivo Roca Luque, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prophylactic Catheter-based VT Ablation
Subjects receive catheter-based ventricular tachycardia (VT) ablation within 3 months of primary ICD implantation.
Procedure: Prophylactic Catheter-based VT Ablation
Prophylactic Catheter-based VT Ablation refers to a treatment strategy where participants undergo a procedure known as catheter-based ventricular tachycardia (VT) ablation shortly after receiving their primary implantable cardioverter defibrillator (ICD).
No Intervention: Continued Medical Management
Subjects undergo continued medical management after primary ICD implantation without prophylactic VT ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Number of VT Arrhythmia Events in High-Risk Patients with Ischemic Cardiomyopathy (ICM) After Primary ICD Implantation: Comparison of Preventive Catheter-Based VT Ablation Versus Medical Management.
Time Frame: One year following ICD implantation.
Evaluating the impact of preventive catheter-based VT ablation versus medical management on the total number of VT arrhythmia events in high-risk patients with ischemic cardiomyopathy (ICM) after primary ICD implantation.
One year following ICD implantation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of Preventive VT Ablation on Healthcare Utilization, assessed using the mean rate of events per arm.
Time Frame: One year following ICD implantation.
Assessing whether preventive VT ablation compared to medical management reduces healthcare resource utilization in high-risk patients with ICM after primary ICD implantation. Healthcare resource utilization will be quantified by averaging planned and unplanned in-office visits, urgent care or emergency room visits, hospitalizations, repeat ablations, or mortality per arm. Data on healthcare utilization will be collected at all follow-up visits (months 3, 6, and 9) and at the end-of-study visit. Analysis will be conducted using a t-test for comparison.
One year following ICD implantation.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of Preventive VT Ablation on the Quality of Life Using the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Time Frame: One year following ICD implantation.
Assessing whether preventive VT ablation compared to medical management enhances quality of life in high-risk patients with ICM after primary ICD implantation, using the Kansas City Cardiomyopathy Questionnaire (KCCQ) to measure quality of life. Scores on the KCCQ range from 0 to 100, with higher scores indicating better quality of life. Data collection with the KCCQ will occur at the Baseline and End of Study visits. Differences in quality of life between the study groups will be analyzed using the t-test based on KCCQ responses.
One year following ICD implantation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2026

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

August 1, 2030

Study Registration Dates

First Submitted

June 17, 2024

First Submitted That Met QC Criteria

August 3, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00009548

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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