Actively Recruiting
Primary Preventive Ventricular Tachycardia Ablation In High-Risk Patients Who Receive A Prophylactic Implantable Cardioverter Defibrillator
Led by University of Rochester · Updated on 2026-04-08
62
Participants Needed
2
Research Sites
236 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Primary Preventive Ventricular Tachycardia Ablation In High-Risk Patients Who Receive A Prophylactic Implantable Cardioverter Defibrillator
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2 18 years (no upper age limit)
- Willing and able to provide informed consent
- Candidate for a primary prevention ICD/CRT-D per ESC guidelines
- Ischemic cardiomyopathy (ICM) with left ventricular ejection fraction (LVEF) 2 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 2 10%)
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Centre Hospitalier Universitaire de Bordeaux
Pessac, France
Actively Recruiting
2
Unidad de Arritimias, Hospital Clínic Barcelona
Barcelona, Spain
Actively Recruiting
Research Team
I
Ilan Goldenberg, MD
CONTACT
M
Misty Ra-Amari, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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