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

December 24, 2013 updated by: Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

Safety and Feasibility of 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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

21

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with severe mitral regurgitation characterized by trans-thoracic and trans-esophageal echocardiography undergoing PMVR using the MitraClip® system

Description

Inclusion Criteria:

  • severe mitral regurgitation
  • PMVR using the MitraClip® system

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
patients will be followed for the duration of procedure until discharge, an expected average of 10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
preparation and procedure time
Time Frame: procedure
procedure
Overall time to discharge
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Participants will be followed for the duration of hospital stay, an expected average of 10 days
Changes in 6-Minute Walk Test
Time Frame: Baseline to 1 month after intervention
Baseline to 1 month after intervention
Changes in NYHA class
Time Frame: Baseline to 1 month after intervention
Baseline to 1 month after intervention
Changes in N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
Time Frame: Baseline to 1 month after intervention
Baseline to 1 month after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Investigators

  • Principal Investigator: Tienush Rassaf, MD, Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Dusseldorf
  • Study Chair: Malte Kelm, MD, Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Dusseldorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

December 12, 2013

First Submitted That Met QC Criteria

December 24, 2013

First Posted (ESTIMATE)

December 30, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 30, 2013

Last Update Submitted That Met QC Criteria

December 24, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MitraClip under sedation

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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