Cardiac Remodeling and Myocardial Perfusion following Mitral Valve Repair with the MitraClip Device

Completed

Conditions: mitral regurgitation
mitral valve leakage
10046973

Registration Number: NL-OMON42395

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 45

Inclusion Criteria

Patients of 18 years and older with moderate to severe mitral regurgitation, scheduled for percutaneous mitral valve repair using the MitraClip at the UMCG.

Exclusion Criteria

Patients will be excluded from this study for any of the following reasons:
- not eligible for percutaneous MitraClip implantation;
- contraindication for CMR imaging (known claustrophobia; ferromagnetic objects in the body, e.g. non-MRI compatible pacemaker);
- general condition which, according to the clinical judgment of the investigator and/or treating physician, does not allow the patient to participate in the study.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the effect of MitraClip implantation on left<br /><br>ventricular end diastolic volume and myocardial blood flow as determined by<br /><br>CMR.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are the effect on outcome as measured by the combined<br /><br>endpoint (severe MR, surgery for mitral valve dysfunction, heart failure<br /><br>hospitalization and death), CMR imaging parameters (including LVEF, left<br /><br>ventricular end systolic volume (ESV), mitral annulus diameter, left atrial<br /><br>diameter, left ventricular mass (LVM), stroke volume (SV), regurgitant volume<br /><br>(RV), wall stress and myocardial fibrosis), and functional change (change in<br /><br>New York Heart Association (NYHA) class and 6 minute walk distance (6MWD)).</p><br>