Status:
NOT_YET_RECRUITING
Primary Preventive Ventricular Tachycardia Ablation In High-Risk Patients Who Receive A Prophylactic Implantable Cardioverter Defibrillator
Lead Sponsor:
University of Rochester
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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. Part...
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) underg...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 15 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2030
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT06543173
Start Date
January 15 2026
End Date
August 1 2030
Last Update
December 15 2025
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