NCT01557842终止4 期
Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 23
- 主要终点
- Percentage of Subjects Who Had Hospitalization for Ventricular Tachycardia (VT) Related Causes/Events
研究概览
简要总结
The purpose of this study is to determine if early ablation (i.e., ablation of ventricular tachycardia in patients with infrequent VT episodes) is more effective than medical therapy alone for the treatment of ischemic ventricular tachycardia in patients with Implantable Cardioverter Defibrillators (ICDs) who continue to have episodes of ventricular tachycardia despite drug therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be drug refractory on Class I-IV AADs (i.e., having VT episodes despite drug therapy)
- •a. Subject must be on at least one AAD at time of enrollment
- •Qualifying episode must be sustained, monomorphic Ventricular Tachycardia post myocardial infarction
- •ICD implanted
- •1 to 3 sustained monomorphic VT episodes requiring appropriate therapy within the previous six (6) months as determined by the investigator
- •History of myocardial infarction documented by the development of pathological Q waves with or without symptoms, imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract in the absence of a nonischemic cause, or pathological findings of a healed or healing myocardial infarction
- •18 years or older
- •Able and willing to comply with all pre- and follow-up testing and requirements
- •Signed Informed Consent Form
排除标准
- •Age < 18 years
- •Documented intra-atrial or ventricular thrombus or other abnormality on preablation echocardiogram
- •Patients with Incessant Ventricular Tachycardia (continuous sustained VTs that recur promptly despite repeated intervention for termination over several (≥ 3) hours)
- •Contraindication to anticoagulation
- •NYHA class IV
- •Left ventricular assist devices (LVADs) or other circulatory assist devices
- •Stroke as confirmed by plasma d-dimer levels or acute myocardial infarction as documented by electrocardiogram or cardiac imaging within the past three (3) months. (Note that a small cardiac enzyme release resulting from being in VT/shocks/etc. is not considered a myocardial infarction.)
- •Patients with active ischemia who are eligible for revascularization
- •Patients with idiopathic Ventricular Tachycardia or Ventricular Tachycardia of non-ischemic cause (such as nonischemic cardiomyopathy)
- •Other disease process likely to limit survival to less than 12 months
- •Serum creatinine of ≥ 2.5mg/dl
- •Thrombocytopenia or coagulopathy
- •Prior ablation for Ventricular Tachycardia
- •Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
- •Enrollment in an study evaluating an investigational device or drug
- •Unable or unwilling to comply with protocol requirements
- •Exclusively Polymorphic Ventricular Tachycardia
研究组 & 干预措施
Treatment Group
Active Comparator
This group receives radiofrequency catheter ablation and drug treatment.
干预措施: Catheter Ablation (Device)
Control Group
Experimental
This group receives only drug treatment.
干预措施: Drug Treatment (Drug)
结局指标
主要结局
Percentage of Subjects Who Had Hospitalization for Ventricular Tachycardia (VT) Related Causes/Events
时间窗: From one month to 2 years follow up
The hospital admission date must occur after completing the 1-month follow-up visit for the event to be considered an effectiveness failure.
Cardiac-related Death
时间窗: 2 years follow up
Subjects with cardiac-related death
次要结局
未报告次要终点
研究者
研究点 (23)
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