NCT06543173

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2026-01-22
• Primary completion: 2030-08-01
• Completion: 2030-08-01
• First posted: 2024-08-07
• Last updated: 2026-04-08

Locations

2 sites across 2 countries: France, Spain