Safety and Feasibility of Deep Sedation Instead of General Anaesthesia in Percutaneous Mitral Valve Repair Using the MitraClip® System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Regurgitation
- Sponsor
- Heinrich-Heine University, Duesseldorf
- Enrollment
- 21
- Primary Endpoint
- Number of patients with adverse Events
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Klinik für Kardiologie, Pneumologie und Angiologie
Director Division of Cardiology, Pulmonary Disease and Vascular Medicine
Heinrich-Heine University, Duesseldorf
Eligibility Criteria
Inclusion Criteria
- •severe mitral regurgitation
- •PMVR using the MitraClip® system
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of patients with adverse Events
Time Frame: 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
Secondary Outcomes
- 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)