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.
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%
Existing ICD or CRT-D
History of sustained VT or VF
Chronic renal failure requiring hemodialysis
Coronary revascularization within the past 3 months
Parallel
Prophylactic Catheter-based VT Ablation
Procedure/SurgeryProphylactic 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).
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.
Impact of Preventive VT Ablation on Healthcare Utilization, assessed using the mean rate of events per arm.
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.
Impact of Preventive VT Ablation on the Quality of Life Using the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Assessing whether preventive VT ablation compared to medical management enhances quality of life in high-risk patients with ICM after primary ICD implantation, using the Kansas City Cardiomyopathy Questionnaire (KCCQ) to measure quality of life. Scores on the KCCQ range from 0 to 100, with higher scores indicating better quality of life. Data collection with the KCCQ will occur at the Baseline and End of Study visits. Differences in quality of life between the study groups will be analyzed using the t-test based on KCCQ responses.
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