Safety and Feasibility of Deep Sedation Instead of General Anaesthesia in Percutaneous Mitral Valve Repair Using the MitraClip® System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 主要终点
- Number of patients with adverse Events
研究概览
简要总结
Percutaneous mitral valve repair (PMVR) with the MitraClip® system has emerged as a therapeutic alternative to surgical valve repair in patients who are at high risk and unsuitable for surgery. The PMVR procedure is typically performed under general anaesthesia, but the MitraClip® is also feasible in deep sedation.
The aim of this study is to investigate the safety of deep sedation in patients undergoing the PMVR procedure and to evaluate how deep sedation in comparison to general anaesthesia influences procedural time and in-hospital stay.
详细描述
Percutaneous mitral valve repair (PMVR) with the MitraClip® system has emerged as a therapeutic alternative to surgical valve repair in patients who are at high risk and unsuitable for surgery.
The PMVR procedure, however, is typically performed under general anaesthesia. It has recently been shown in a first approach that performing the MitraClip® in deep sedation is feasible; however safety parameters and a direct comparison to general anaesthesia are still missing The aim of this study is to investigate the safety of deep sedation in patients undergoing the PMVR procedure and to evaluate how deep sedation in comparison to general anaesthesia influences procedural time and in-hospital stay.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •severe mitral regurgitation
- •PMVR using the MitraClip® system
排除标准
- 未提供
结局指标
主要结局
Number of patients with adverse Events
时间窗: patients will be followed for the duration of procedure until discharge, an expected average of 10 days
Evaluation of feasibility and safety of deep sedation instead of general anaesthesia
次要结局
- Overall time to discharge(Participants will be followed for the duration of hospital stay, an expected average of 10 days)
- Changes in 6-Minute Walk Test(Baseline to 1 month after intervention)
- preparation and procedure time(procedure)
- Changes in NYHA class(Baseline to 1 month after intervention)
- Changes in N-terminal prohormone of brain natriuretic peptide (NT-proBNP)(Baseline to 1 month after intervention)
研究者
Klinik für Kardiologie, Pneumologie und Angiologie
Director Division of Cardiology, Pulmonary Disease and Vascular Medicine
Heinrich-Heine University, Duesseldorf