Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure
Trial Parameters
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Brief Summary
CASTLE-VT is a randomized evaluation of prophylactic ablative treatment of arrhythmogenic ventricular scar in patients referred for HTx evaluation and diagnosed with ICM. Ablation will be performed with the use of a substrate-based approach in which the myocardial scar is mapped and ablated while the heart remains predominantly in sinus rhythm. The primary end point is the composite of all-cause mortality, worsening of HF requiring prioritized transplantation or LVAD implantation. The main secondary study end points are all-cause mortality, cardiovascular mortality, incidence of implantable cardioverter-defibrillator (ICD) therapy, hospitalizations, Quality of life, time to first ICD therapy, number of device-detected ventricular tachycardia/ventricular fibrillation episodes, LV function, and exercise tolerance. CASTLE-VT will randomize 160 patients with a follow up period of 2 years.
Eligibility Criteria
Inclusion Criteria: 1. Ischemic cardiomyopathy with left ventricular ejection fraction ≤ 35% (measured in the last 6 weeks prior to enrollment) 2. Eligible for heart transplantation due to end-stage heart failure 3. NYHA class ≥ III 4. Impaired functional capacity or inability to exercise 5. Indication for ICD therapy due to primary prevention 6. Implanted ICD or ICD implantation within 3 months after randomization 7. The patient is willing and able to comply with the protocol and has provided written informed consent 8. Age ≥ 18 years Exclusion Criteria: 1. Previous catheter ablation for ventricular arrhythmias 2. Previous appropriate ICD-therapy for ventricular arrhythmias 3. Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 4 weeks prior to enrollment 4. Untreated hypothyroidism or hyperthyroidism 5. Woman currently pregnant, breastfeeding, or not using reliable contraceptive measures during fertility age 6. Mental or physical inability to par