No registrations found.
ID
Source
Brief title
Health condition
Mitral regurgitation; percutaneous mitral valve repair; MitraClip.
Mitralisklepinsufficiëntie; percutane mitralisklep reparatie.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in left ventricular end diastolic volume (EDV) and myocardial blood flow (MBF).
Secondary outcome
End systolic volume, left ventricular ejection fraction, stroke volume, regurgitant volume, mitral annulus diameter, left atrial size, left ventricular mass, wall strass, native T1, extracellular volume.
Background summary
We aim to study the effect of the MitraClip implantation on myocardial performance as determined by changes in left ventricular end diastolic volume and myocardial perfusion, in 45 patients in the University Medical Center Groningen.
Study objective
We hypothesize that percutaneous edge-to-edge mitral valve repair using MitraClip reduces left ventricular end diastolic volume and improves myocardial perfusion.
Study design
T0a (inclusion)
T0b (first CMR assessment)
T1 (MitraClip implantation)
T2a (second CMR assessment)
T2b (outpatient clinic visit at 6 months)
T3 (outpatient clinic visit at 1 year)
Intervention
Cardiovascular magnetic resonance imaging (CMR) before MitraClip implantation and at 4 months after implantation.
Inclusion criteria
In order to be eligible to participate in this study, a subject must be scheduled for percutaneous mitral valve repair using the MitraClip.
Exclusion criteria
Patients will be excluded from this study for any of the following reasons:
- not eligible for percutaneous MitraClip implantation;
- pregnancy or lactation;
- contraindication for CMR imaging (known claustrophobia; tattoos containing metallic dyes; body mass >250 kg;, 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;.
- patients with a high degree atrioventricular block will be excluded from adenosine administration.
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 |
|---|---|
| NTR-new | NL6354 |
| NTR-old | NTR6538 |
| Other | METc Groningen : 2015.176 |