Physiological Changes of the Mitral Annulus After Annuloplasty in Barlow Disease

NCT04418960 | Unknown

• 1 other identifier: 2018-02240; ch20Grapow
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Barlow Disease (BD); Mitral Insufficiency

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in anatomical structures by MRI

  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

  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.

Secondary Outcomes (1)

• function of the mitral valve by echocardiography

  during the hospital stay, between 3 and 7 days after the operation and at cardiological follow-up over the first 3 months.

Interventions

Magnetic resonance imaging (MRI) DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients referred to cardiac surgery clinic (University Hospital Basel) through cardiologist meeting the inclusion criteria based on the medical history, clinical and echocardiographic findings.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Cardiac Surgery, University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Martin Grapow, Prof. Dr. med.

  HerzZentrum Hirslanden, Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Grapow, Prof. Dr. med.

CONTACT

+41 44 3873711; grapow@herzzentrum.ch

Thibault Schaeffer

CONTACT

+41 61 328766; Thibault.schaeffer@usb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: June 5, 2020
• Study Start: September 21, 2018
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: August 3, 2021

Record last verified: 2021-08

Locations

CH (1)