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

Mitral Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02023762
• Other study ID #: MitraClip under sedation
• Status: Completed
• Phase: N/A
• First received: December 12, 2013
• Last updated: December 24, 2013
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethic Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• severe mitral regurgitation

• PMVR using the MitraClip® system

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Local Anaesthesia
• Mitral Regurgitation
• Mitral Valve Insufficiency
• Percutaneous Repair

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	preparation and procedure time		procedure	No
Secondary	Overall time to discharge		Participants will be followed for the duration of hospital stay, an expected average of 10 days	No
Secondary	Changes in 6-Minute Walk Test		Baseline to 1 month after intervention	No
Secondary	Changes in NYHA class		Baseline to 1 month after intervention	No
Secondary	Changes in N-terminal prohormone of brain natriuretic peptide (NT-proBNP)		Baseline to 1 month after intervention	Yes

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