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MitraClip® After Surgical Mitral Valve Repair (MVRepair)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02853955
Recruitment Status : Unknown
Verified July 2016 by Daniel Braun, MD, Klinikum der Universitaet Muenchen.
Recruitment status was:  Recruiting
First Posted : August 3, 2016
Last Update Posted : September 1, 2016
Sponsor:
Information provided by (Responsible Party):
Daniel Braun, MD, Klinikum der Universitaet Muenchen

Brief Summary:
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.

Condition or disease Intervention/treatment
Mitral Regurgitation Device: Percutaneous edge-to-edge repair of the mitral valve

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: MitraClip® for the Treatment of Recurrent Severe Mitral Regurgitation After Surgical Mitral Valve Repair
Study Start Date : May 2016
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : November 2016

Intervention Details:
  • Device: Percutaneous edge-to-edge repair of the mitral valve
    MitraClip in patients with recurrent MI after surgical mitral valve repair.


Primary Outcome Measures :
  1. Survival [ Time Frame: 1 year ]
  2. MR (mitral regurgitation) grade after clip treatment [ Time Frame: 1 year ]
    Scale 0-4


Secondary Outcome Measures :
  1. MR (mitral regurgitation) grade at latest follow up [ Time Frame: 1 year ]
    Scale 0-4

  2. NYHA status at latest follow up [ Time Frame: 1 year ]
  3. Distance in 6 minute walk test at latest follow up [ Time Frame: 1 year ]
  4. LVEF (left ventricular ejection fraction) at latest follow up [ Time Frame: 1 year ]
  5. LVEDV (left ventricular enddiastolic volume) at latest follow up [ Time Frame: 1 year ]
  6. LVEDD (lef ventricular enddiastolic diameter) at latest follow up [ Time Frame: 1 year ]
  7. Mean mitral valve gradient [ Time Frame: 1 year ]
  8. Procedural complications [ Time Frame: index procedure ]
  9. 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)

  10. Clip success based on type of sMVR [ Time Frame: index procedure ]
    success defined as reduction of 1 MR grade (scale 0-4)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients treated with a MitraClip® after sMVR
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853955


Contacts
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Contact: Daniel Braun, MD +49 89 4400 ext 73052 Daniel.Braun@med.uni-muenchen.de
Contact: Jörg Hausleiter, MD +49 89 4400 ext 72360 Joerg.Hausleiter@med.uni-muenchen.de

Locations
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Germany
Munich University Hospital Recruiting
Munich, Bavaria, Germany, 81377
Contact: Daniel Braun, MD    +49894400 ext 73052    Daniel.Braun@med.uni-muenchen.de   
Contact: Joerg Hausleiter, MD    +49894400 ext 72360    Joerg.Hausleiter@med.uni-muenchen.de   
Sponsors and Collaborators
Klinikum der Universitaet Muenchen
Investigators
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Study Chair: Jörg Hausleiter, MD LMU Munich
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Responsible Party: Daniel Braun, MD, MD, Klinikum der Universitaet Muenchen
ClinicalTrials.gov Identifier: NCT02853955    
Other Study ID Numbers: GE IDE MucS001-16
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases