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

Recruiting now · Not applicable

Conditions studied: Heart Failure, Arrhythmia, Ventricular, Cardiomyopathy Ischemic, Catheter Ablation, Heart Transplantation, Left Ventricular Assist Device

In brief

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.

Key facts

Study ID

NCT06556485

Run by

Heart and Diabetes Center North-Rhine Westfalia

People needed

160

Starts

2024-09-13

Expected to finish

2027-01-01

Last updated by the study team

2024-12-04

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Indication for ICD therapy due to primary prevention
• Implanted ICD or ICD implantation within 3 months after randomization
• The patient is willing and able to comply with the protocol and has provided written informed consent
• Age ≥ 18 years

You may not qualify if…

• 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
• Woman currently pregnant, breastfeeding, or not using reliable contraceptive measures during fertility age
• Mental or physical inability to participate in the study
• Listed as "high urgent" for heart transplantation
• Cardiac assist device implanted
• Planned cardiovascular intervention
• Life expectancy ≤ 12 month
• Uncontrolled hypertension
• Requirement for dialysis due to end-stage renal failure

Where it is running

• Clinic for Electrophysiology, Herz- und Diabeteszentrum NRW — Bad Oeynhausen, Germany (enrolling)

Full record on ClinicalTrials.gov

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