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.
Ischemic cardiomyopathy with left ventricular ejection fraction ≤ 35% (measured in the last 6 weeks prior to enrollment)
Eligible for heart transplantation due to end-stage heart failure
NYHA class ≥ III
Impaired functional capacity or inability to exercise
Previous catheter ablation for ventricular arrhythmias
Previous appropriate ICD-therapy for ventricular arrhythmias
Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 4 weeks prior to enrollment
Untreated hypothyroidism or hyperthyroidism
Parallel
Catheter ablation
Procedure/SurgeryPreventive ablation therapy
Medical therapy
DrugOptimal medical therapy
Primary end point
Composite of all-cause mortality, worsening of HF requiring prioritized transplantation or LVAD implantation
Secondary end point 1
all-cause mortality, cardiovascular mortality
Secondary end point 2
incidence of implantable cardioverter-defibrillator (ICD) therapy, hospitalizations, number of device-detected ventricular tachycardia/ventricular fibrillation episodes
Secondary end point 3
Quality of life, time to first ICD therapy
Secondary end point 4
LV function, exercise tolerance
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