Randomized Controlled Phase IV Multicentric Trial, Comparing the Efficacy and Safety of Radiofrequency Substrate Ablation of Monomorphic Ventricular Tachycardia vs. Antiarrhyhtmic Drugs in Patients Experiencing Appropriate ICD Shocks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Occurrence of hospitalization for heart failure
研究概览
简要总结
To compare the efficacy and safety of substrate-based radiofrequency catheter ablation vs. antiarrhythmic drug therapy in patients with ischemic cardiomyopathy and scar-related sustained monomorphic ventricular tachycardia.
详细描述
Sustained monomorphic ventricular tachycardia remains an important source of morbidity and mortality in patients surviving a myocardial infarction. ICD´s have been proven to reduce mortality in this patients population, nonetheless, recurrent arrhythmia and ICD shocks are known to negatively impact ventricular function and are associated with worsening heart failure and mortality. We devised a controlled, randomized, parallel, single blind, phase IV clinical trial with the aim of comparing the efficacy and safety of substrate-based radiofrequency catheter ablation vs. antiarrhythmic drug therapy in patients with ischemic cardiomyopathy and scar-related sustained monomorphic ventricular tachycardia, implanted with an ICD.
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
- Single (Outcomes Assessor)
盲法说明
ICD therapy analysis and outcome adjudication is performed by physicians blinded to the study group.
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
- •Ischemic cardiomyopathy, with ischemic myocardial scar
- •Sustained monomorphic ventricular tachycardia
- •Age > 18 years
- •Prior ICD implantation
排除标准
- •NYHA functional class IV
- •Additional indication for antiarrhythmic drug therapy
- •Contraindication for both study drugs (amiodarone and sotalol).
- •Uncontrolled myocardial ischemia.
- •LV thrombus.
- •Non-ischemic VT substrate.
- •Contraindications for anticoagulation.
- •Prior substrate ablation in the previous 6 months
- •Cr > 2.5 mg/dL
- •Mitral AND aortic mechanical valvular prosthesis
研究组 & 干预措施
Ablation
Substrate-based radiofrequency catheter ablation
干预措施: Ablation (Procedure)
Antiarrhythmic drug therapy
Antiarrhythmic drug therapy; amiodarone or sotalol
干预措施: Antiarrhythmic drug (Drug)
结局指标
主要结局
Occurrence of hospitalization for heart failure
时间窗: 2 years
- Hospitalization for heart failure requiring overnight hospital stay and either increased oral diuretics or intravenous diuretics (at least 40 mg od frusemide or 10 mg od torasemide).
Occurrence of severe complication of the ablation procedure.
时间窗: 2 years
Occurrence of severe complications of the ablation procedure Will be identified through review of patient clinical reports
Occurrence of interruption of antiarrhythmic drug therapy due to severe side effects
时间窗: 2 years
Occurrence of severe complications of the ablation procedure Will be identified through review of patient clinical reports
Occurrence of death from cardiovascular causes.
时间窗: 2 years
- Cause of death will be established by evaluation of medical records by an endpoints adjudication committee. Cardiovascular death includes: sudden death, death due to worsening heart failure or death due to myocardial infarction
Occurrence of appropriate shocks for VT/VF
时间窗: 2 years
Occurrence of appropriate shocks for VT/VF VT is measured by ICD interrogation, which is routinely done at the following follow-up visits: after the VT ablation procedure, or in case of suspected arrhythmic symptoms (palpitations, syncope or presyncope).
次要结局
- Number of patients with inappropriate ICD therapies(2 years)
- Number of patients with appropriate ICD therapies(2 years)
- Number of patients with inappropriate ICD shocks(2 years)
- Quality of life measured with the The Short Form (36) Health Survey(2 years)
- Number of patients with appropriate ICD shocks(2 years)