Deep Sedation Instead of General Anaesthesia in Percutaneous Mitral Valve Repair Using the MitraClip® System

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Feasibility of Deep Sedation Instead of General Anaesthesia in Percutaneous Mitral Valve Repair Using the MitraClip® System

Conditions
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Mitral Regurgitation, Local Anaesthesia, Percutaneous Repair

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: severe mitral regurgitation PMVR using the MitraClip® system Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse Events | Evaluation of feasibility and safety of deep sedation instead of general anaesthesia | patients will be followed for the duration of procedure until discharge, an expected average of 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preparation and procedure time |  | procedure | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mitral regurgitation, local anaesthesia, percutaneous repair