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

NCT02023762 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 21

Last updated 2013-12-30

No results posted yet for this study

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.

Conditions

  • Mitral Regurgitation
  • Local Anaesthesia
  • Percutaneous Repair

Sponsors & Collaborators

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • Tienush Rassaf, MD · Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Dusseldorf

  • Malte Kelm, MD · Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Dusseldorf

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-12-31
Completion
2013-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02023762 on ClinicalTrials.gov