Physiological Changes of the Mitral Annulus After Annuloplasty in Barlow Disease

Mitral Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04418960
• Other study ID #: 2018-02240; ch20Grapow
• Status: Recruiting
• Start date: September 21, 2018
• Est. completion date: April 2022

Study information

• Verified date: August 2021
• Source: University Hospital, Basel, Switzerland
• Contact: Martin Grapow, Prof. Dr. med.
• Phone: +41 44 3873711
• Email: grapow[@]herzzentrum.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barlow Disease (BD)
• Mitral Insufficiency
• Mitral Valve Insufficiency

Intervention

Diagnostic Test:
• Magnetic 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.

Locations

Country	Name	City	State
Switzerland	Cardiac Surgery, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.