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

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.

Study Overview

• Status: Recruiting
• Conditions: Mitral Insufficiency; Barlow Disease (BD)
• Intervention / Treatment: Diagnostic test: Magnetic resonance imaging (MRI)

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: Name: Martin Grapow, Prof. Dr. med.; Phone Number: +41 44 3873711; Email: grapow@herzzentrum.ch
• Study Contact Backup: Name: Thibault Schaeffer; Phone Number: +41 61 328766; Email: Thibault.schaeffer@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • Cardiac Surgery, University Hospital Basel
    • Contact: Martin Grapow, Prof. Dr. med.; Phone Number: +41 44 3873711; Email: grapow@herzzentrum.ch
    • Contact: Thibault Schaeffer; Phone Number: +41 61 3285766; Email: Thibault.Schaeffer@usb.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
function of the mitral valve by echocardiography	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.	during the hospital stay, between 3 and 7 days after the operation and at cardiological follow-up over the first 3 months.

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Martin Grapow, Prof. Dr. med., HerzZentrum Hirslanden, Zurich

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2018
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 3, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: mitral valve repair; mitral annuloplasty; mitral annulus; coaptation of mitral leaflets
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: 2018-02240; ch20Grapow

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No