NCT06543173 Primary Preventive Ventricular Tachycardia Ablation In High-Risk Patients Who Receive A Prophylactic Implantable Cardioverter Defibrillator
| NCT ID | NCT06543173 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Rochester |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2026-01-22 |
| Primary Completion | 2030-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 62 participants in total. It began in 2026-01-22 with a primary completion date of 2030-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06543173 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06543173 currently recruiting?
Yes, NCT06543173 is actively recruiting participants. Contact the research team at Ilan_Goldenberg@URMC.Rochester.edu for enrollment information.
Where is the NCT06543173 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Pau, France, Chambray-lès-Tours, France, Pessac, France and 1 additional location.
Who is sponsoring the NCT06543173 clinical trial?
NCT06543173 is sponsored by University of Rochester. The trial plans to enroll 62 participants.
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