Prolonged Continuous ECG Monitoring Prior to TrAnscatheter AoRtic ValvE Implantation: the PARE 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
- 106
- 试验地点
- 2
- 主要终点
- Arrhythmic events
研究概览
简要总结
Patients with severe aortic stenosis candidates for a TAVI procedure harbor a high burden of silent arrhythmic events. Pre-procedural detection of such arrhythmias should help the investigators to implement specific therapeutic measures that may improve patient outcomes and reduce hospitalization length post-TAVI.
详细描述
This is a 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 within the 3 months prior to the TAVI procedure. The duration of the ECG monitoring will be of 1 week. There will be no 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 occurrence of the arrhythmic event. Following the TAVI procedure, the patients will be monitored (telemetry) until hospital discharge. All arrhythmic events during the hospitalization period will be recorded. Clinical follow-up will be performed at 30 days, and 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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe aortic stenosis accepted for a TAVI procedure by the Heart Team.
排除标准
- •Urgent TAVI procedure or logistic reasons precluding an ECG monitoring of at least 1 week within the 3 months prior to the TAVI procedure.
- •Prior permanent pacemaker.
结局指标
主要结局
Arrhythmic events
时间窗: Within 3 months prior to the TAVI procedure
Incidence and type of arrhythmic events
Therapeutic changes
时间窗: Within 3 months prior to the TAVI procedure
incidence of arrhythmic events identified by the device leading to therapeutic changes prior to the TAVI procedure
次要结局
- Atrioventricular block(Within 3 months prior to the TAVI procedure)
- Severe bradycardia(Within 3 months prior to the TAVI procedure)
- Left bundle branch block(Within 3 months prior to the TAVI procedure)
- Permanent pacemaker(Within 3 months prior to the TAVI procedure)
- Anticoagulation therapy(Within 3 months prior to the TAVI procedure)
- Atrial fibrillation(Within 3 months prior to the TAVI procedure)
研究者
Josep Rodes-Cabau
Principal investigator
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec