Assessment of Arrhythmic BuRdEn With Post-ProCedural COntinuous ElectRocarDiographic Monitoring in Patients Undergoing Transcatheter Aortic Valve Implantation: The RECORD Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Incidence of arrhythmic events
研究概览
简要总结
TAVI recipients exhibit a high burden of arrhythmic events early after the procedure. ECG continuous monitoring could be useful to diagnose and facilitate early implementation of specific therapeutic measures in these patients.
详细描述
Prospective registry including patients accepted by the heart team for a TAVI procedure. Patients will undergo a prolonged continuous ECG monitoring using the CardioSTAT® device after hospital discharge. Following the TAVI procedure, continuous ECG monitoring will start just before hospital discharge and prolonged up to 4 weeks. There won't be any restriction regarding the type of valve and approach used for the TAVI procedure.
All type of arrhythmic events will be recorded, as well as the specific therapeutic measures implemented upon the diagnosis of the arrhythmic event.
Analyses of the CardioSTAT will be done at 2 and 4 weeks following hospital discharge. Clinical follow-up will be performed at 14 days (analysis of CardioSTAT® record), 28 days (analysis of CardioSTAT record), 1 year post-TAVI and yearly thereafter up to 5-year follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients with severe aortic stenosis undergoing TAVI with either balloon or self-expandable valves.
排除标准
- •Failure to provide informed consent.
- •Prior or post-procedural pacemaker
- •In-hospital death
- •Logistic reasons precluding ECG monitoring within the 4 weeks after the procedure
- •Participation in another continuous ECG monitoring post-TAVI trial
结局指标
主要结局
Incidence of arrhythmic events
时间窗: within the first weeks after the procedure, an average of 4 weeks
Incidence of arrhythmic events after discharge in TAVI recipients.
Type of arrhythmic events
时间窗: within the first weeks after the procedure, an average of 4 weeks
Type of arrhythmic events after discharge in TAVI recipients.
Type of arrhythmic events and treatment modification
时间窗: within the first weeks after the procedure, an average of 4 weeks
Type of arrhythmic events leading to a specific change in treatment.
Incidence of arrhythmic events and treatment modification
时间窗: within the first weeks after the procedure, an average of 4 weeks
Incidence of arrhythmic events leading to a specific change in treatment.
次要结局
- Number of participants with treatment modification(Through study completion, an average of 5 years)
- Number of participants with pacemaker(Through study completion, an average of 5 years)
研究者
Josep Rodes-Cabau
MD, Principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval