We hypothesize that percutaneous edge-to-edge mitral valve repair using MitraClip reduces left ventricular end diastolic volume and improves myocardial perfusion.
ID
Bron
Verkorte titel
Aandoening
Mitral regurgitation; percutaneous mitral valve repair; MitraClip.
Mitralisklepinsufficiëntie; percutane mitralisklep reparatie.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Change in left ventricular end diastolic volume (EDV) and myocardial blood flow (MBF).
Achtergrond van het onderzoek
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.
Doel van het onderzoek
We hypothesize that percutaneous edge-to-edge mitral valve repair using MitraClip reduces left ventricular end diastolic volume and improves myocardial perfusion.
Onderzoeksopzet
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)
Onderzoeksproduct en/of interventie
Cardiovascular magnetic resonance imaging (CMR) before MitraClip implantation and at 4 months after implantation.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In order to be eligible to participate in this study, a subject must be scheduled for percutaneous mitral valve repair using the MitraClip.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6354 |
| NTR-old | NTR6538 |
| Ander register | METc Groningen : 2015.176 |