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NCT Number: NCT06543173

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Righospitalet, Copenhagen, Region H, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prophylactic Catheter-based VT Ablation

Procedure

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ilan Goldenberg, MD

CONTACT

[email protected]

585-275-5391

Misty Ra-Amari, BA

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Acronym: PREVENT-VT

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Aug 7, 2024
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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