Prevalence and Significance of Bradycardic Arrhythmias and Conduction Abnormalities Among Patients With Severe Aortic Stenosis Before and After Transcatheter Aortic Valve Replacement Using Extended Heart Rhythm Recording (Brady-TAVR Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Need for Pacemaker post TAVR
研究概览
简要总结
Most of the conduction abnormalities with TAVR are usually detected during the procedure or during the following days of observation. Little is known about the prevalence and timing of any conduction abnormalities that exist before (other than standard ECG) or after through long term cardiac monitoring.
详细描述
Each subject who fulfills the inclusion/exclusion criteria will be provided with Zio patch for 2 weeks before TAVR. Immediately after the procedure, patients will be admitted per TAVR protocol and will be on telemetry. Data about their ECGs and any arrhythmias will be collected.
Upon discharge, patients will be provided with another Zio patch for 2 weeks. At the 2-3 months follow up, subjects will be provided with a third Zio patch for 2 weeks
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Age > 18 and <90 years old
- •Able to provide informed consent
- •Willing to follow up at Cleveland Clinic (per TAVR protocol)
排除标准
- •Prior CIED (Pacemaker or defibrillator)
- •Unable to provide consent
- •Unable to follow up at Cleveland Clinic per TAVR protocol
结局指标
主要结局
Need for Pacemaker post TAVR
时间窗: 2 months prior to TAVR
the prevalence of brady arrhythmia (Sinus brady, Sinus Pauses, AV Block, Bundle Branch Block) among patients with severe aortic stenosis who undergo TAVR using an extended cardiac rhythm monitor (Zio Patch) and determine if the brady arrhythmias predict the need for a pacemaker.
次要结局
- Prevalence of brady arrhythmia after discharge from hospital post TAVR(3 weeks post discharge)
- Prevalence of delayed brady arrhythmia post TAVR(2 months post TAVR)
- Prevalence of in hospital brady arrhythmia post TAVR(72 hours post TAVR)
研究者
Khaldoun Tarakji
Principal Investigator
The Cleveland Clinic