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Magnetic Resonance Imaging study to evaluate the effect of MitraClip implantation


- candidate number26847
- NTR NumberNTR6538
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-mrt-2017
- Secondary IDs2015.176 METc Groningen
- Public TitleMagnetic Resonance Imaging study to evaluate the effect of MitraClip implantation
- Scientific TitleCardiac Remodeling and Myocardial Perfusion following Mitral Valve Repair with the MitraClip Device
- ACRONYMMRI-MC
- hypothesisWe hypothesize that percutaneous edge-to-edge mitral valve repair using MitraClip reduces left ventricular end diastolic volume and improves myocardial perfusion.
- Healt Condition(s) or Problem(s) studiedMitral valve insufficiency, Percutaneous mitral valve repair
- Inclusion criteriaIn order to be eligible to participate in this study, a subject must be scheduled for percutaneous mitral valve repair using the MitraClip.
- Exclusion criteriaPatients 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-jun-2015
- planned closingdate31-mei-2019
- Target number of participants45
- InterventionsCardiovascular magnetic resonance imaging (CMR) before MitraClip implantation and at 4 months after implantation.
- Primary outcomeChange in left ventricular end diastolic volume (EDV) and myocardial blood flow (MBF).
- Secondary outcomeEnd 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.
- TimepointsT0a (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)
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIESProf. Dr. P. van der Harst
- CONTACT for SCIENTIFIC QUERIESProf. Dr. P. van der Harst
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Abbott
- PublicationsNone so far.
- Brief summaryWe 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.
- Main changes (audit trail)
- RECORD15-mrt-2017 - 23-jul-2017


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