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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02023762

Enrollment

Registered

2013-12-30

Start date

2012-01-31

Completion date

2013-12-31

Last updated

2013-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Local Anaesthesia, Mitral Regurgitation, Percutaneous Repair

Keywords

mitral regurgitation, local anaesthesia, percutaneous repair

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* severe mitral regurgitation * PMVR using the MitraClip® system

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	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

Outcome results