Primary Preventive Ventricular Tachycardia Ablation In High-Risk Patients Who Receive A Prophylactic Implantable Cardioverter Defibrillator

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

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

Conditions2

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