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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Preventive ablation therapy
Optimal medical therapy
Clinic for Electrophysiology, Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany
RECRUITINGPrimary end point
Composite of all-cause mortality, worsening of HF requiring prioritized transplantation or LVAD implantation
Time frame: through study completion, an average of 2 years
Secondary end point 1
all-cause mortality, cardiovascular mortality
Time frame: through study completion, an average of 2 years
Secondary end point 2
incidence of implantable cardioverter-defibrillator (ICD) therapy, hospitalizations, number of device-detected ventricular tachycardia/ventricular fibrillation episodes
Time frame: through study completion, an average of 2 years
Secondary end point 3
Quality of life, time to first ICD therapy
Time frame: through study completion, an average of 2 years
Secondary end point 4
LV function, exercise tolerance
Time frame: through study completion, an average of 2 years
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