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Completed

NCT Number: NCT02023762

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

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.

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Key information

Conditions

Mitral Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Local Anaesthesia Mitral Valve Insufficiency Percutaneous Repair

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • severe mitral regurgitation
  • PMVR using the MitraClip® system

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. Number of patients with adverse Events

    Time frame: 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 outcomes

  1. preparation and procedure time

    Time frame: procedure

  2. Overall time to discharge

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days

  3. Changes in 6-Minute Walk Test

    Time frame: Baseline to 1 month after intervention

  4. Changes in NYHA class

    Time frame: Baseline to 1 month after intervention

  5. Changes in N-terminal prohormone of brain natriuretic peptide (NT-proBNP)

    Time frame: Baseline to 1 month after intervention

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 30, 2013
Registry last updated
Dec 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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