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

NCT06543173 | Recruiting DMC

• 1 other identifier: STUDY00009548
• Study Type: interventional
• Target: 62
• Locations: 3 countries
• Sites: 5

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  One year following ICD implantation.

Secondary Outcomes (1)

• Impact of Preventive VT Ablation on Healthcare Utilization, assessed using the mean rate of events per arm.

  One year following ICD implantation.

Other Outcomes (1)

• Impact of Preventive VT Ablation on the Quality of Life Using the Kansas City Cardiomyopathy Questionnaire (KCCQ).

  One year following ICD implantation.

Study Arms (2)

Prophylactic Catheter-based VT Ablation

EXPERIMENTAL

Subjects receive catheter-based ventricular tachycardia (VT) ablation within 3 months of primary ICD implantation.

Procedure: Prophylactic Catheter-based VT Ablation

Continued Medical Management

NO INTERVENTION

Subjects undergo continued medical management after primary ICD implantation without prophylactic VT ablation.

Interventions

Prophylactic Catheter-based VT Ablation PROCEDURE

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).

Prophylactic Catheter-based VT Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (5)

Righospitalet

Copenhagen, Region H, 2800, Denmark

RECRUITING

Centre Hospitalier De Pau

Pau, Gave de Pau, 64000, France

RECRUITING

Hopital Trousseau Chru de Tours

Chambray-lès-Tours, Indre-et-Loire, 37170, France

RECRUITING

Centre Hospitalier Universitaire de Bordeaux

Pessac, France

RECRUITING

Unidad de Arritimias, Hospital Clínic Barcelona

Barcelona, Spain

RECRUITING

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MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Ilan Goldenberg, MD

CONTACT

585-275-5391; Ilan_Goldenberg@URMC.Rochester.edu

Misty Ra-Amari, BA

CONTACT

Misty_RaAmari@URMC.Rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ilan Goldenberg, MD, Professor of Medicine

Model Details: Subjects will be randomized in a 1:1 fashion to undergo either prophylactic catheter-based ventricular tachycardia (VT) ablation within 3 months of primary ICD implantation or continued medical management after ICD implantation.

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: August 7, 2024
• Study Start: January 22, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: May 19, 2026

Record last verified: 2026-04

Locations

FR (3); ES (1); DK (1)