Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure rEfferred for Heart Transplantation eValuaTion (CASTLE-VT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Primary end point
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Ablation group
Primary prophylactic ablation
干预措施: Catheter ablation (Procedure)
Control group
Optimal medical therapy
干预措施: Medical therapy (Drug)
结局指标
主要结局
Primary end point
时间窗: through study completion, an average of 2 years
Composite of all-cause mortality, worsening of HF requiring prioritized transplantation or LVAD implantation
次要结局
- 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)