MitraClip® After Surgical Mitral Valve Repair (MVRepair)

August 31, 2016 updated by: Daniel Braun, MD, LMU Klinikum

MitraClip® for the Treatment of Recurrent Severe Mitral Regurgitation After Surgical Mitral Valve Repair

Percutaneous edge-to-edge repair of the mitral valve has been shown to be a safe and effective alternative treatment option for selected patients at high risk for cardiac surgery. Patients with recurrent mitral regurgitation after surgical mitral valve repair (sMVR) are per se at increased risk for another cardiac surgery. The purpose of this multicenter retrospective analysis of patients treated with a MitraClip® after sMVR, is to evaluate the effectiveness and durability of this minimally invasive treatment option in this subset of patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In this multicenter retrospective analysis of MitraClip® cases after MVR the effectiveness and durability of this minimally invasive treatment option in this subset of patients will be evaluated.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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 to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients treated with a MitraClip® after sMVR

Description

Inclusion Criteria:

  • All patients with recurrent mitral regurgitation treated with a MitraClip®.

Exclusion Criteria:

  • Patient with endocarditis,
  • Patients with torn mitral valve ring.

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
Survival
Time Frame: 1 year
1 year
MR (mitral regurgitation) grade after clip treatment
Time Frame: 1 year
Scale 0-4
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MR (mitral regurgitation) grade at latest follow up
Time Frame: 1 year
Scale 0-4
1 year
NYHA status at latest follow up
Time Frame: 1 year
1 year
Distance in 6 minute walk test at latest follow up
Time Frame: 1 year
1 year
LVEF (left ventricular ejection fraction) at latest follow up
Time Frame: 1 year
1 year
LVEDV (left ventricular enddiastolic volume) at latest follow up
Time Frame: 1 year
1 year
LVEDD (lef ventricular enddiastolic diameter) at latest follow up
Time Frame: 1 year
1 year
Mean mitral valve gradient
Time Frame: 1 year
1 year
Procedural complications
Time Frame: index procedure
index procedure
Death, recurrent mitral regurgitation grade > 2, repeat intervention/operation of mitral valve
Time Frame: 1 year
combined endpoint defined as freedom from each Event (death, MR grade >2 or reintervention/Operation)
1 year
Clip success based on type of sMVR
Time Frame: index procedure
success defined as reduction of 1 MR grade (scale 0-4)
index procedure

Collaborators and Investigators

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

Sponsor

LMU Klinikum

Investigators

  • Study Chair: Jörg Hausleiter, MD, LMU Munich

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

May 1, 2016

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

March 31, 2016

First Submitted That Met QC Criteria

July 29, 2016

First Posted (Estimate)

August 3, 2016

Study Record Updates

Last Update Posted (Estimate)

September 1, 2016

Last Update Submitted That Met QC Criteria

August 31, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE IDE MucS001-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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