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Clinical Trials/NCT05836376
NCT05836376
Completed
Not Applicable

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

Michele De Bonis1 site in 1 country55 target enrollmentNovember 30, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mitral Regurgitation
Sponsor
Michele De Bonis
Enrollment
55
Locations
1
Primary Endpoint
Mortality
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 30, 2020
End Date
December 2, 2020
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Michele De Bonis

Chief of Cardiac Surgery of Advanced and Research Therapies

Ospedale San Raffaele

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Mortality

Time Frame: 30 days

Study Sites (1)

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