Heart Failure
Conditions
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.
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) undergoing primary implantable cardioverter defibrillator (ICD) implantation. The primary outcome measure is the burden of VT arrhythmias (VTA), defined as the total number of VT events, one year post-ICD implantation. The hypothesis suggests that employing VT ablation with high-density electroanatomic mapping (EnsiteTM) will significantly reduce both treated and monitored VT episodes. The study will randomize 62 participants in a 1:1 ratio across 20 experienced sites in Europe.
Interventions
PROCEDUREProphylactic 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).
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Preventive VT Ablation on Healthcare Utilization, assessed using the mean rate of events per arm. | One year following ICD implantation. | Assessing whether preventive VT ablation compared to medical management reduces healthcare resource utilization in high-risk patients with ICM after primary ICD implantation. Healthcare resource utilization will be quantified by averaging planned and unplanned in-office visits, urgent care or emergency room visits, hospitalizations, repeat ablations, or mortality per arm. Data on healthcare utilization will be collected at all follow-up visits (months 3, 6, and 9) and at the end-of-study visit. Analysis will be conducted using a t-test for comparison. |
Countries
Denmark, France, Spain
Contacts
CONTACTIlan Goldenberg, MD
CONTACTMisty Ra-Amari, BA
Outcome results
None listed