Clinical Trial

Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure

Study acronym: CASTLE-VT
Recruiting
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Record status
This record was last updated December 4, 2024 (before its estimated June 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-08-13.
Status change: Not Yet Recruiting → Recruiting 2024-12-01
Trial Details
NCT Number NCT06556485
Lead Sponsor Heart and Diabetes Center North-Rhine Westfalia
Conditions Heart Failure, Arrhythmia, Ventricular, Cardiomyopathy Ischemic, Catheter Ablation, Heart Transplantation, Left Ventricular Assist Device
Enrollment 160 participants
Start Date 2024-09-13
Primary Completion 2026-06-01 (estimated)
Study Completion 2027-01-01 (estimated)
Updated on ClinicalTrials.gov 2024-12-04