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Physiological Changes of the Mitral Annulus After Annuloplasty in Barlow Disease

Physiological Changes of the Mitral Annulus After Annuloplasty in Barlow Disease: an MRI-focused Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04418960
Enrollment
10
Registered
2020-06-05
Start date
2018-09-21
Completion date
2022-04-30
Last updated
2021-08-03

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

Conditions

Barlow Disease (BD), Mitral Insufficiency

Keywords

mitral annuloplasty, mitral valve repair, mitral annulus, coaptation of mitral leaflets

Brief summary

Barlow disease (BD) is a common cause of mitral insufficiency. In 2012 the University Hospital of Basel started to perform a simplified mitral valve repair technique in BD just by implanting an annuloplasty-ring. It is hypothesized that the major mechanism of the valvular insufficiency in Barlow disease is a deformation of the left ventricle and the posterior mitral annulus, causing its aberrant displacement during the systole towards posterior and basal and thus impairing the coaptation of the leaflets. This prospective individual MRI study is to investigate the ventricle and the mitral annulus pre- and postoperatively for detailed analysis.

Interventions

DIAGNOSTIC_TESTMagnetic resonance imaging (MRI)

MRI pre- and postoperatively for detailed analysis of the ventricle and the mitral annulus. The first MRI will be performed on the admission day before surgery. The second MRI will be performed during the hospital stay, between 3 and 7 days after the operation. The MRI images are interpreted through a specialized cardiologist and radiologist.

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* identified Barlow disease suffering from significant mitral insufficiency with indication to surgery

Exclusion criteria

* Active endocarditis or any other etiology of mitral insufficiency else than Barlow disease * Inability to perform a cardiac MRI (e.g., metallic implants, claustrophobia) * Pregnancy * Inability to give consent

Design outcomes

Primary

MeasureTime frameDescription
Change in anatomical structures by MRIThe first MRI will be performed on the admission day before surgery. The second MRI will be performed during the hospital stay, between 3 and 7 days after the operation.Change in anatomical structures by MRI: distance (mm) between the mitral annulus and the cardiac apex during the cardiac cycle before and after surgical correction

Secondary

MeasureTime frameDescription
function of the mitral valve by echocardiographyduring the hospital stay, between 3 and 7 days after the operation and at cardiological follow-up over the first 3 months.association between reduction of movement of the posterior annulus and the function of the valve after surgery (i.e. its residual insufficiency (0 = absent, 1 = mild, 2 = moderate, 3 = severe)). Evaluated with echocardiography as it is routinely performed in cardiac surgery.

Countries

Switzerland

Contacts

Primary ContactMartin Grapow, Prof. Dr. med.
grapow@herzzentrum.ch+41 44 3873711
Backup ContactThibault Schaeffer
Thibault.schaeffer@usb.ch+41 61 328766

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026