Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure rEfferred for Heart Transplantation eValuaTion (CASTLE-VT)
Overview
- Phase
- Not Applicable
- Intervention
- Catheter ablation
- Conditions
- Heart Failure
- Sponsor
- Heart and Diabetes Center North-Rhine Westfalia
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Primary end point
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Ablation group
Primary prophylactic ablation
Intervention: Catheter ablation
Control group
Optimal medical therapy
Intervention: Medical therapy
Outcomes
Primary Outcomes
Primary end point
Time Frame: through study completion, an average of 2 years
Composite of all-cause mortality, worsening of HF requiring prioritized transplantation or LVAD implantation
Secondary Outcomes
- Secondary end point 3(through study completion, an average of 2 years)
- Secondary end point 1(through study completion, an average of 2 years)
- Secondary end point 2(through study completion, an average of 2 years)
- Secondary end point 4(through study completion, an average of 2 years)