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

Completed

• Conditions: Mitral Regurgitation; Local Anaesthesia; Percutaneous Repair

• Registration Number: NCT02023762
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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.

Study Timeline

• Study Start: 2012-01
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2013-12-12
• Study First Submitted QC: 2013-12-24
• Last Update Submitted: 2013-12-24
• Study First Posted: 2013-12-30
• Last Update Posted: 2013-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• severe mitral regurgitation
• PMVR using the MitraClip® system

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse Events	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 Outcome Measures

Name	Time	Method
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