Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure
Recruiting · NCT06556485 · Interventional (participants receive a specific treatment) · Lead sponsor: Heart and Diabetes Center North-Rhine Westfalia
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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
1 location listed.
- Clinic for Electrophysiology, Herz- und Diabeteszentrum NRW - Bad Oeynhausen, Germany