Is Mitral Annuloplasty an Effective Treatment for Severe Atrial Functional MR?

Mitral Regurgitation Clinical Trial

Official title:

Is Mitral Annuloplasty an Effective Treatment for Severe Atrial Functional MR?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05836376
• Other study ID #: MAT-SAFMR
• Status: Completed
• Start date: November 30, 2020
• Est. completion date: December 2, 2020

Study information

• Verified date: April 2023
• Source: Ospedale San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Atrial functional mitral regurgitation (MR) is caused by annular dilatation and flattering associated with altered atria/annulus dynamics in patients with severely dilated left atrium and normal leaflets anatomy. Inadequate leaflets adaption is considered a mechanistic culprit as well. Prevalence of at least moderate atrial functional MR varies between 4.7% and 7% in patients with permanent and long standing persistent atrial fibrillation (AF) and is even higher in patients with Heart Failure with preserved Ejection Fraction (HFpEF). Unlike secondary MR in the setting of left ventricular disease, results of surgical treatment of severe atrial functional MR has remained largely unspoken. The aim of this study is to analyze short and mid-term results of isolated annuloplasty in patients with severe, symptomatic atrial functional MR, in comparission to a matched cohort of patients with secondary MR.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2, 2020
• Est. primary completion date: December 2, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Atrial MR group Inclusion criteria

• Adult patients, underwent mitral annuloplasty for atrial functional mitral Anatomical criteria
• Annular dilatation with anterior-posterior diameter (AP) in systole >35mm
• Ratio of AP diameter in systole to anterior leaflet length in diastole >1.3
• Normal leaflets anatomy
• Mild fibrosis may be present
• A small cleft may be present as a result of annular dilatation Functional criteria
• Normal leaflet mobility (Carpentier type I)
• Coaptation depth <10mm
• Absence of ventricular tethering
• Centrality of the regurgitant jet Atrial and ventricular characteristics
• Left atrium diameter > 40 mm
• Normal systolic function of the left ventricle
• Mild left ventricular systolic dysfunction Mild LV (tachycardia induced) with EF >45%
• Absence of regional abnormalities in left ventricular wall motion Clinical criteria
• Persistent, long-standing persistent, or permanent atrial fibrillation Exclusion criteria
• Degenerative MR including congenital clefts
• LVEF < 45%
• Ventricular tethering
• Coaptation depth >10 mm
• Regional abnormalities in left ventricular wall motion
• Sinus rhythm
• Presence of coronary artery disease
• Absence of annular dilatation Non-atrial MR group Inclusion criteria
• Adult patients underwent cardiac surgery for non-atrial functional mitral regurgitation in the setting of an idiopathic or ischemic cardiomyopathy Exclusion criteria
• FE<40%
• Concomitant coronary artery bypass graft
• Age <65 years and >75years
• Treated with annuloplasty + edge-to-edge surgery
• Sinus rhythm

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Procedure:
• Mitral valve annuloplasty
implantation of a prosthetic ring to treat mitral valve regurgitation

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Michele De Bonis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		30 days