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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02853955
Other study ID # GE IDE MucS001-16
Secondary ID
Status Recruiting
Phase N/A
First received March 31, 2016
Last updated August 31, 2016
Start date May 2016
Est. completion date November 2016

Study information

Verified date July 2016
Source Klinikum der Universitaet Muenchen
Contact Daniel Braun, MD
Phone +49 89 4400
Email Daniel.Braun@med.uni-muenchen.de
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date November 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 95 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Patient with endocarditis,

- Patients with torn mitral valve ring.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Germany Munich University Hospital Munich Bavaria

Sponsors (1)

Lead Sponsor Collaborator
Klinikum der Universitaet Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival 1 year No
Primary MR (mitral regurgitation) grade after clip treatment Scale 0-4 1 year No
Secondary MR (mitral regurgitation) grade at latest follow up Scale 0-4 1 year No
Secondary NYHA status at latest follow up 1 year No
Secondary Distance in 6 minute walk test at latest follow up 1 year No
Secondary LVEF (left ventricular ejection fraction) at latest follow up 1 year No
Secondary LVEDV (left ventricular enddiastolic volume) at latest follow up 1 year No
Secondary LVEDD (lef ventricular enddiastolic diameter) at latest follow up 1 year No
Secondary Mean mitral valve gradient 1 year No
Secondary Procedural complications index procedure No
Secondary Death, recurrent mitral regurgitation grade > 2, repeat intervention/operation of mitral valve combined endpoint defined as freedom from each Event (death, MR grade >2 or reintervention/Operation) 1 year No
Secondary Clip success based on type of sMVR success defined as reduction of 1 MR grade (scale 0-4) index procedure No
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