Ventricular Tachycardia Antiarrhythmics or AblatioN In Structural Heart Disease 2
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- John Sapp
- 入组人数
- 416
- 试验地点
- 22
- 主要终点
- Appropriate ICD shock at least 14 days post randomization
研究概览
简要总结
A multicenter, randomized clinical trial to assess whether catheter ablation or antiarrhythmic drug therapy provides the most effective control of important clinical outcomes for patients with prior myocardial infarction and sustained monomorphic ventricular tachycardia (VT).
详细描述
Implantable Defibrillators (ICDs) reduce sudden death and can terminate some VT without shocks, but they don't prevent VT; the most appropriate strategy to suppress VT remains unknown. Two randomized clinical trials have suggested that catheter ablation can significantly reduce the incidence of subsequent VT in patients after an initial episode. Neither trial, however, compared catheter ablation to active antiarrhythmic drug therapy. Randomized trials of antiarrhythmic drug therapy have demonstrated that therapy with either sotalol or amiodarone can reduce recurrent VT. Both antiarrhythmic drug and ablation therapy suffer from imperfect efficacy and the potential for significant side-effects. No study has compared ablation to drug therapy for first-line treatment. The VANISH study which compared ablation to aggressive antiarrhythmic drug therapy for patients who have failed initial drug therapy was published in May 2016, and demonstrated that for patients with drug-refractory VT, catheter ablation was superior to escalation of antiarrhythmic drug therapy. Benefits were seen in the group which had VT despite amiodarone. Event rates were similar between amiodarone and sotalol for patients with VT occurring despite sotalol, who were randomized to either new initiation of amiodarone or catheter ablation. These results do not address the clinical question of the most appropriate first line therapy for suppression of VT in persons with prior myocardial infarction, an ICD and VT.
The trial hypothesis is: catheter ablation will, in comparison to antiarrhythmic drug therapy reduce the composite outcome of death at any time, appropriate ICD shock after 14 days, ventricular tachycardia storm after 14 days or treated sustained ventricular tachycardia below the detection rate of the ICD for patients with prior myocardial infarction and sustained monomorphic ventricular tachycardia.
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 and
- •One of the following VT events while not being treated with amiodarone, sotalol, or another class I or class III antiarrhythmic drug) within the last 6 months:
- •Sustained monomorphic VT documented on 12-lead ECG or rhythm strip terminated by pharmacologic means or DC cardioversion
- •≥3 episodes of VT treated with antitachycardia pacing (ATP), at least one of which was symptomatic
- •≥ 5 episodes of VT treated with antitachycardia pacing (ATP) regardless of symptoms
- •≥1 appropriate ICD shocks,
- •≥3 VT episodes within 24 hours
排除标准
- •Unable or unwilling to provide informed consent.
- •Active ischemia (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of VT (e.g. drug-induced arrhythmia), had recent acute coronary syndrome within 30 days, coronary revascularization (<90 days bypass surgery, <30 days percutaneous coronary intervention), or have CCS functional class IV angina. Note that biomarker level elevation alone after ventricular arrhythmias does not denote acute coronary syndrome or active ischemia.
- •Are ineligible to take the antiarrhythmic drug to which they would be assigned due to allergy, intolerance or contraindication
- •Are known to have protruding left ventricular thrombus or mechanical aortic and mitral valves
- •Have had a prior catheter ablation procedure for VT
- •Presenting arrhythmia: polymorphic VT or ventricular fibrillation (VF)
- •Are in renal failure (Creatinine clearance <15 mL/min), have NYHA Functional class IV heart failure, or a systemic illness likely to limit survival to <1 year
- •Have had recent ST elevation myocardial infarction or non-ST elevation MI (< 30 days); note that biomarker elevation alone after ventricular arrhythmias does not denote MI.
- •Are pregnant.
研究组 & 干预措施
VT catheter ablation
Catheter ablation of ventricular tachycardia
干预措施: Catheter ablation (Procedure)
Antiarrhythmic Drug Therapy
Patients will be prescribed either oral amiodarone or sotalol daily (dosage and frequency to be determined based on patient's clinical presentation at the time of the qualifying arrhythmia).
干预措施: Antiarrythmic Drug Therapy (Drug)
结局指标
主要结局
Appropriate ICD shock at least 14 days post randomization
时间窗: 8 years (including pilot study data)
Time to first appropriate ICD shock after 14 days post randomization
VT storm at least 14 days post randomization
时间窗: 8 years (including pilot study data)
Time to 3 or more episodes of VT within 24 hours
All-cause mortality
时间窗: 8 years (including pilot study data)
Time to any death occurring at any time post randomization
Sustained VT requiring treatment at least 14 days post randomziation
时间窗: 8 years (including pilot study data)
Time to any sustained VT greater below the detection rate of the ICD requiring cardioversion (electrical or chemical) or manual ICD therapy at least 14 days post randomization
次要结局
- VT storm at any time or after 14 days(8 years (including pilot study data))
- Sustained VT not treated by ICD at any time or after 14 days(8 years (including pilot study data))
- Any ICD shock at any time or after 14 days(6 years (including pilot study data))
- Number of ICD shocks (all cause)(8 years (including pilot study data))
- Number of VT storm events(8 years (including pilot study data))
- Number of sustained VT events(8 years (including pilot study data))
- All-cause mortality at any time(8 years (including pilot study data))
- Appropriate shocks at any time or after 14 days(8 years (including pilot study data))
- Time to sustained VT treated with appropriate any type of manual cardioversion after 14 days(8 years (including pilot study data))
- Number of ICD appropriate therapy(8 years (including pilot study data))
- Hospital admission for cardiac causes(8 years (including pilot study data))
- Serious adverse events(8 years (including pilot study data))
- Quality of life - SF36(8 years (including pilot study data))
- Quality of life - HADS(8 years (including pilot study data))
- Cost-effectiveness(8 years (including pilot study data))
- Escalation and De-escalation of antiarrhythmic medication(8 years (including pilot study data))
- Appropriate ICD ATP at any time or after 14 days(8 years (including pilot study data))
- Number of Anti-tachycardia pacing (ATP)(8 years (including pilot study data))
- Ablation procedural complications or antiarrhythmic drug adverse effects (this may require a separate substudy, depending on data complexity)(8 years (including pilot study data))
- Quality of life - EQ5D(8 years (including pilot study data)))
- ICD Revision(8 years (including pilot study data))
- Inappropriate ICD shocks at any time or after 14 days(8 years (including pilot study data))
- Any ventricular arrhythmia event at any time or after 14 days (composite of appropriate ATP, appropriate shock, sustained VT not treated by ICD, external cardioversion, or pharmacologic cardioversion)(8 years (including pilot study data))
- Side effects from anti-arrhythmic medication(8 years (including pilot study data))
- Number of ventricular arrhythmia events(8 years (including pilot study data))
研究者
John Sapp
Staff Physician, Division of Cardiology
Nova Scotia Health Authority