Predictive Value of Pre-Transcatheter Aortic Valve Implantation (TAVI) Infrahissian Conduction Time in the Occurrence of Complete Atrioventricular Block in Patients With Preoperative Right Bundle Branch Block
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Implantation of a Pacemaker at 30 days
研究概览
简要总结
The purpose of the study is implantation of a Pacemaker at 30 days for occurrence of a high-grade conduction disorder per- or post-procedure (yes/no)
详细描述
The main objective is to assess the predictive value of the pre-TAVI infrahelic conduction time interval (infraheal conduction time measured before percutaneous aortic valve implantation) on the risk of Pacemaker implantation at 30 days post-TAVI, in patients with right bundle branch block prior to surgery.
The aim of the study is to identify a pre-interventional marker of the risk of rhythmological complication after the TAVI procedure (Transcatheter Aortic Valve Implantation), in order to better anticipate it.
This is an interventional, prospective, longitudinal (follow-up: 12 months), multicenter (4 centers) study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient suffering from severe aortic stenosis, eligible for a TAVI procedure (Transcatheter Aortic Valve Implantation) ;
- •Patient presenting with complete right bundle branch block during the pre-TAVI electrocardiogram, with QRS interval ≥ 120 ms (depolarization of the ventricles);
- •Patient able to understand the information related to the study, to read the information leaflet and agreeing to participate in the study. ;
- •Patient having signed a consent.
排除标准
- •Contraindication to Transcatheter Aortic Valve Implantation ;
- •Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
- •Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
- •Patient not benefiting from a social security scheme.
结局指标
主要结局
Implantation of a Pacemaker at 30 days
时间窗: 30 days
Implantation of a Pacemaker at 30 days for occurrence of a high-grade conduction disorder per- or post-procedure (yes/no)
次要结局
未报告次要终点