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

NCT05836376 | Completed

• 1 other identifier: MAT-SAFMR
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• Mortality

  30 days

Study Arms (2)

Function Atrial MR

Procedure: Mitral valve annuloplasty

Functiona Non-atrial MR

Procedure: Mitral valve annuloplasty

Interventions

Mitral valve annuloplasty PROCEDURE

implantation of a prosthetic ring to treat mitral valve regurgitation

Function Atrial MR; Functiona Non-atrial MR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated for functional mitral regurgitation with annuloplasty. Study group will comprehend patients with atrial functional mitral regurgitation, the control group will be of patients with non-atrial functional mitral regurgitation

You may qualify if:

• 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

You may not qualify if:

• 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
• Adult patients underwent cardiac surgery for non-atrial functional mitral regurgitation in the setting of an idiopathic or ischemic cardiomyopathy
• FE\<40%
• Concomitant coronary artery bypass graft
• Age \<65 years and \>75years
• Treated with annuloplasty + edge-to-edge surgery
• Sinus rhythm

Sponsors & Collaborators

• Michele De Bonis: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Interventions

Mitral Valve Annuloplasty

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Valve Annuloplasty; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Cardiac Surgery of Advanced and Research Therapies

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: May 1, 2023
• Study Start: November 30, 2020
• Primary Completion: December 2, 2020
• Study Completion: December 2, 2020
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)