RecruitingNot ApplicableNCT06556485

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

Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure rEfferred for Heart Transplantation eValuaTion (CASTLE-VT)

Sponsor

Heart and Diabetes Center North-Rhine Westfalia

Enrollment

160 participants

Start Date

Sep 13, 2024

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether performing a catheter ablation procedure (using energy to destroy abnormal heart tissue) can prevent dangerous heart rhythm problems and reduce the need for a heart transplant in people with severe heart failure who are being considered for transplant. **You may be eligible if...** - You have severe heart failure from ischemic heart disease (heart attack-related) with very low pumping function (ejection fraction ≤ 35%) - You are being evaluated for heart transplant (NYHA Class III or higher) - You have a defibrillator (ICD) or are planning to get one within 3 months - You are 18 or older and physically able to participate **You may NOT be eligible if...** - You have already had catheter ablation for heart rhythm problems - You have already had appropriate shocks from your ICD for heart rhythm problems - You recently had a heart attack, heart surgery, or stroke (within 4 weeks) - You have untreated thyroid disease - You are pregnant or planning pregnancy - You are on dialysis or have very limited life expectancy (less than 12 months) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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