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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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%)

Locations
Other Locations
France
Centre Hospitalier Universitaire de Bordeaux
RECRUITING
Pessac
Spain
Unidad de Arritimias, Hospital Clínic Barcelona
RECRUITING
Barcelona
Contact Information
Primary
Ilan Goldenberg, MD
Ilan_Goldenberg@URMC.Rochester.edu
585-275-5391
Backup
Misty Ra-Amari, BA
Misty_RaAmari@URMC.Rochester.edu
Time Frame
Start Date: 2026-01-22
Estimated Completion Date: 2030-08-01
Participants
Target number of participants: 62
Treatments
Experimental: Prophylactic Catheter-based VT Ablation
Subjects receive catheter-based ventricular tachycardia (VT) ablation within 3 months of primary ICD implantation.
No_intervention: Continued Medical Management
Subjects undergo continued medical management after primary ICD implantation without prophylactic VT ablation.
Sponsors
Leads: University of Rochester

This content was sourced from clinicaltrials.gov