Ventricular Tachycardia Ablation or Escalated aNtiarrhythmic Drugs in ISchemic Heart Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- John Sapp
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Appropriate ICD shocks,VT storm and death
研究概览
简要总结
This study will compare aggressive antiarrhythmic therapy to catheter ablation for ventricular tachycardia in patients who have suffered prior myocardial infarction. The purpose of this study is to evaluate the optimal management of patients presenting with recurrent VT and receiving ICD therapy in spite of first-line antiarrhythmic drug therapy. The hypothesis is catheter ablation is superior to aggressive antiarrhythmic drug therapy for recurrent VT.
详细描述
This is a multicentre, parallel group, two arm, unblinded, randomized clinical trial to compare two management strategies for patients with ischemic heart disease and recurrent ICD therapy despite at least one antiarrhythmic drug. The primary endpoint will be a composite of appropriate ICD shocks or death.
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
- •Prior Myocardial Infarction
- •An implantable defibrillator
- •One of the following VT events (within the past 3 months):
- •greater than or equal to 3 episodes of symptomatic VT treated with ATP
- •greater than or equal to 1 appropriate ICD shock
- •greater than or equal to 3 VT episodes within 24 hours
- •sustained VT below detection rate of the ICD documented by ECG
- •"Failed" first-line antiarrhythmic drug therapy as defined by one of:
- •Appropriate ICD therapy or sustained VT occurred while patient was taking amiodarone (stable dose >/= 2 weeks)
- •Appropriate ICD therapy or sustained VT occurred on another antiarrhythmic drug (stable dose >/= 2 weeks)
排除标准
- •Active ischemia (acute thrombus, dynamic ST elevation on ECG) or another reversible cause of VT (eg. electrolyte abnormalities, drug induced arrhythmia)
- •Are known to be ineligible to take amiodarone (eg. active hepatitis, current hyperthyroidism, pulmonary fibrosis, known allergy)
- •Are ineligible for ablation (left ventricular thrombus, implanted mechanical aortic and mitral valves)
- •Renal Failure (creatinine clearance < 15 ml/min)
- •Current NYHA functional class IV heart failure or CCS Functional Class IV angina
- •Recent ST elevation myocardial infarction (< 1 month)
- •Recent coronary bypass surgery (< 3 mon) or recent PCI (< 1 mon)
- •prior ablation for ventricular tachycardia
- •A systemic illness likely to limit survival to < 1 year
- •Unable or unwilling to provide informed consent
研究组 & 干预措施
Ventricular Tachycardia Ablation
Catheter ablation for Ventricular tachycardia will be performed within 14 days of randomization.
干预措施: Catheter Ablation (Procedure)
Escalated Antiarrhythmic Drug Therapy
Patients are prescribed a loading dose of amiodarone or the addition of mexiletine to their current anti-arrhythmic medication which is stratified by the dose and type of antiarrhymic medication at the time of the index arrhythmic event.
干预措施: Escalated Antiarrhythmic Therapy (Drug)
结局指标
主要结局
Appropriate ICD shocks,VT storm and death
时间窗: 3 years
次要结局
- All cause mortality(3 years)
- Appropriate ICD antitachycardia pacing anytime and after 1 month treatment period(3 years)
- appropriate ICD shocks anytime and after 1 month treatment period(3 years)
- Procedural complications, amiodarone toxicity or adverse events(3 years)
- Inappropriate shocks anytime and after 1 month treatment period(3 years)
- Number of ICD shocks(3 years)
- Hospital admission for cardiac causes(3 years)
- VT storm anytime and after 1 month treatment period(3 years)
- Documented sustained VT below detection rate of the ICD any time and after 1 month treatment period(3 years)
研究者
John Sapp
Staff physician, Division of Cardiology
Nova Scotia Health Authority