NL-OMON36099已完成4 期
Ventricular Tachycardia Ablation vs. ENhanced Drug Therapy In Structural Heart Disease - VANISH study
The Queen Elizabeth II Health Sciences Centre0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •1. Prior myocardial infarction (pathological Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause)73
- •2. An implantable defibrillator
- •3. One of the following VT events (within last 3 months):
- •A: *3 episodes of symptomatic VT treated with antitachycardia pacing (ATP),
- •B: *1 appropriate ICD shocks,
- •C: *3 VT episodes within 24 hr
- •D: sustained VT below detection rate of the ICD documented by ECG/cardiac monitor
- •4. *Failed* first-line antiarrhythmic drug therapy (Class 1 or 3) as defined by one of:
- •A: Appropriate ICD therapy or sustained VT occurred while the patient was taking amiodarone (patient on a stable dose for * 2 weeks)
- •B: Appropriate ICD therapy or sustained VT occurred on another antiarrhythmic drug (patient on a stable dose for * 2 weeks)
排除标准
- •1. Are unable or unwilling to provide informed consent.
- •2. Have an acute coronary syndrome (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of VT (e.g. electrolyte abnormalities, drug-induced arrhythmia)
- •3. Are known to be ineligible to take amiodarone, e.g. active hepatitis, current hyperthyroidism, pulmonary fibrosis, known allergy.
- •4. Are ineligible for ablation (known to have protruding left ventricular thrombus, or have implanted mechanical aortic and mitral valves)
- •5. Are in renal failure (Creatinine clearance <15 ml/min)
- •6. Have current NYHA Functional class IV heart failure or CCS Functional class IV angina
- •7. Had recent ST elevation myocardial infarction (< 1 month)
- •8. Had recent coronary bypass surgery (< 3 months) or percutaneous coronary intervention (<1 month)
- •9. Are pregnant
- •10. Have had prior ablation for ventricular tachycardia
- •11. Have a systemic illness likely to limit survival to < 1 year.
研究者
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