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Magnetic Resonance Imaging study to evaluate the effect of MitraClip implantation

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON29348
Enrollment
45
Registered
2017-03-15
Start date
2015-06-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Mitral regurgitation

Interventions

Cardiovascular magnetic resonance imaging (CMR) before MitraClip implantation and at 4 months after implantation.

Sponsors

University Medical Center Groningen
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Change in left ventricular end diastolic volume (EDV) and myocardial blood flow (MBF).

Secondary

MeasureTime frame
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.

Contacts

Public ContactP. van der Harst
p.van.der.harst@umcg.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)