International Multicenter Project Comparing Radiofrequency Ablation Versus Implantable Defibrillator After Well-tolerated Ventricular Tachycardia in Ischemic Heart Disease With Minimally Impaired Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 268
- 试验地点
- 2
- 主要终点
- Monitoring for the occurrence of at least one serious event during the 36 months of follow-up
研究概览
简要总结
Evidence for the usefulness of the defibrillator in cases of preserved left ventricular ejection fraction and well-tolerated ventricular tachycardia (without cardiocirculatory arrest or syncope) is lacking, as no previous trials have included such patients. Additionally, sudden death in this particular population is low compared to other subgroups of patients with malignant ventricular arrhythmias.
On the other hand, numerous recent retrospective data show that ablation of ventricular tachycardia can reduce mortality, and also clearly reduces the number of recurrences in prospective studies.
Finally, a very low rate of sudden death was observed in a multicenter European retrospective study that we conducted, including patients with well-tolerated ventricular tachycardia in structural heart disease with minimally impaired ejection fraction and benefiting from ablation without implantation of defibrillator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ischemic heart disease with history of infarction - LVEF> 35% (measured by MRI)
- •sustained monomorphic ventricular tachycardia - without history of syncope or cardiac arrest -
- •having signed informed consent
- •affiliated to a social security system
排除标准
- •transient regressive cause of ventricular tachycardia
- •recent myocardial infarction (<2 months)
- •ventricular tachycardia by reentry from branch to branch
- •serious conduction disturbances (with indication of stimulation)
- •contraindication to the implantation of a defibrillator or to the performance of an ablation (life expectancy <1 year, relevant comorbidities)
- •pregnancy
- •age <18 years
- •Patient under legal protection, guardianship or curatorship
研究组 & 干预措施
Implantation of an automatic defibrillator
Implantation of an automatic defibrillator
干预措施: Adverse events collection (Other)
Implantation of an automatic defibrillator
Implantation of an automatic defibrillator
干预措施: Quality of life questionnaire EQ-5D-5L (Other)
Implantation of an automatic defibrillator
Implantation of an automatic defibrillator
干预措施: Medical-economic evaluation (Other)
Percutaneous catheter ablation
Percutaneous catheter ablation
干预措施: Adverse events collection (Other)
Percutaneous catheter ablation
Percutaneous catheter ablation
干预措施: Quality of life questionnaire EQ-5D-5L (Other)
Percutaneous catheter ablation
Percutaneous catheter ablation
干预措施: Medical-economic evaluation (Other)
结局指标
主要结局
Monitoring for the occurrence of at least one serious event during the 36 months of follow-up
时间窗: 36 months
Monitoring of the occurrence of death from any cause, hospitalization or emergency consultation for any event related to ventricular arrhythmia or its treatment (recurrence of ventricular tachycardia or complication linked to the defibrillator or crossover from one group to another)
次要结局
未报告次要终点