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Recruiting Not applicable

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

NCT06543173 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-01-22
Last updated
2026-05-19

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

Prophylactic Catheter-based VT Ablation

Prophylactic Catheter-based VT Ablation: Prophylactic Catheter-based VT Ablation refers to a treatment strategy where participants undergo a procedure known as catheter-based ventricular tachycardia (VT) ablation shortly after receiving their primary implantable cardioverter defibrillator (ICD).

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Total Number of VT Arrhythmia Events in High-Risk Patients with Ischemic Cardiomyopathy (ICM) After Primary ICD Implantation: Comparison of Preventive Catheter-Based VT Ablation Versus Medical Management. — One year following ICD implantation.
    Evaluating the impact of preventive catheter-based VT ablation versus medical management on the total number of VT arrhythmia events in high-risk patients with ischemic cardiomyopathy (ICM) after primary ICD implantation.

Trial sites (5)

FacilityCityRegionStatus
Righospitalet Copenhagen Region H Recruiting
Centre Hospitalier De Pau Pau Gave de Pau Recruiting
Hopital Trousseau Chru de Tours Chambray-lès-Tours Indre-et-Loire Recruiting
Centre Hospitalier Universitaire de Bordeaux Pessac France Recruiting
Unidad de Arritimias, Hospital Clínic Barcelona Barcelona Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06543173 on ClinicalTrials.gov ↗ ← All trials in France