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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42395

Enrollment

Registered

2015-06-30

Start date

2015-08-18

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mitral regurgitation mitral valve leakage

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Secondary

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

Measure

Time frame

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

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Primary

Measure	Time frame
The primary endpoint is the effect of MitraClip implantation on left ventricular end diastolic volume and myocardial blood flow as determined by CMR.	—

Countries

Netherlands

Outcome results