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

Sponsor

Michele De Bonis (Other)

Overall Status

Completed

CT.gov ID

NCT05836376

Collaborator

(none)

55

Enrollment

1

Location

2

Actual Duration (Days)

837

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mitral Regurgitation	Procedure: Mitral valve annuloplasty

Study Design

Study Type:

Observational

Actual Enrollment :

55 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Nov 30, 2020

Actual Primary Completion Date :

Dec 2, 2020

Actual Study Completion Date :

Dec 2, 2020

Arms and Interventions

Arm

Intervention/Treatment

Function Atrial MR

Procedure: Mitral valve annuloplasty

implantation of a prosthetic ring to treat mitral valve regurgitation

Functiona Non-atrial MR

Procedure: Mitral valve annuloplasty

implantation of a prosthetic ring to treat mitral valve regurgitation

Outcome Measures

Primary Outcome Measures

Mortality [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Ospedale San Raffaele	Milan		Italy	20132

Sponsors and Collaborators

Michele De Bonis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michele De Bonis, Chief of Cardiac Surgery of Advanced and Research Therapies, Ospedale San Raffaele

ClinicalTrials.gov Identifier:

NCT05836376

Other Study ID Numbers:

MAT-SAFMR

First Posted:

May 1, 2023

Last Update Posted:

May 1, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

No

Plan to Share IPD:

No

Studies a U.S. FDA-regulated Drug Product:

No

Studies a U.S. FDA-regulated Device Product:

No

Additional relevant MeSH terms:

Mitral Valve Insufficiency

Study Results

No Results Posted as of May 1, 2023