Changes in Infranodal Conduction Times and New Onset Left Bundle Branch Block: Possible Predictors for High-grade AV Block Following Transcatheter Aortic Valve Replacement
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- High-degree AV block
研究概览
简要总结
Consecutive patients with high grade aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) with a self-expanding valve (Medtronic CoreValve Evolut R® or Edwards Sapien S3®) without pre-existing pacemaker devices are eligible for inclusion. During the TAVR procedure, an electrophysiologic study including measurements of infranodal conduction times (HV-interval before and after valve implantation) will be performed. Electrocardiograms before TAVR, before discharge, after 30 days and after 12 months will be analyzed regarding new onset LBB and the occurrence of high-degree AV block (HAVB) .
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for TAVR according to current guidelines
- •Written informed consent
排除标准
- •Pre-existent intracardiac device as pacemaker, implanted cardioverter defibrillator or CRT-P/CRT-D device
研究组 & 干预措施
EPS arm
Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR
干预措施: Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR (Diagnostic Test)
结局指标
主要结局
High-degree AV block
时间窗: 24 months
Occurence of high-degree AV block necessitating a pacemaker implantation during follow up
Persistence of left bundle-branch block
时间窗: 24 months
Persistence of new onset left bundle branch-block following TAVR procedure
次要结局
- Differences between implanted valve types on ifranodal conduction(24 months)
研究者
Christian Ukena
Principal Investigator
University Hospital, Saarland