To study the effect of the MitraClip implantation on myocardial performance as determined by changes in left ventricular end diastolic volume and myocardial perfusion.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the effect of MitraClip implantation on left
ventricular end diastolic volume and myocardial blood flow as determined by
CMR.
Secondary outcome
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)).
Background summary
Percutaneous edge-to-edge mitral valve repair using the MitraClip reduces
Mitral Regurgitation (MR) in selected high risk patients deemed inoperable.
Several pilot studies showed significant improvement in left ventricular
dimensions after MitraClip implantation using echocardiography or Cardiac
Magnetic Resonance imaging (CMR), suggesting reverse left ventricular
remodeling. The effect on Left Ventricular Ejection Fraction (LVEF) differs
between studies. Some physicians suggest that percutaneous edge-to-edge mitral
valve repair results in elevated wall stress. Myocardial perfusion, wall stress
and myocardial fibrosis are associated with the development and prognosis of
heart failure. However, the effect of MitraClip implantation on these
parameters has not been studied before.
Study objective
To study the effect of the MitraClip implantation on myocardial performance as
determined by changes in left ventricular end diastolic volume and myocardial
perfusion.
Study design
Observational cohort study of 45 patients in the University Medical Center
Groningen (UMCG). Before and four months after MitraClip implantation CMR
stress perfusion imaging will be performed to assess changes in myocardial
performance. Total study duration is 24 months.
Study burden and risks
N/A
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | nctnummervolgt |
| CCMO | NL53339.042.15 |