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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-12-31

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.

Conditions

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Mitral Regurgitation Local Anaesthesia Percutaneous Repair

Keywords

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mitral regurgitation local anaesthesia percutaneous repair

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* severe mitral regurgitation
* PMVR using the MitraClip® system

Exclusion Criteria

\-

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Klinik für Kardiologie, Pneumologie und Angiologie

Director Division of Cardiology, Pulmonary Disease and Vascular Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tienush Rassaf, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Dusseldorf

Malte Kelm, MD

Role: STUDY_CHAIR

Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Dusseldorf

References

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Rassaf T, Balzer J, Zeus T, Rammos C, Shayganfar S, Hall SV, Wagstaff R, Kelm M. Safety and efficacy of deep sedation as compared to general anaesthesia in percutaneous mitral valve repair using the MitraClip system. Catheter Cardiovasc Interv. 2014 Oct 1;84(4):E38-42. doi: 10.1002/ccd.25570. Epub 2014 Jul 4.

Reference Type DERIVED

PMID: 24909413 (View on PubMed)

Other Identifiers

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MitraClip under sedation

Identifier Type: -

Identifier Source: org_study_id