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OpenTrials
Completed

NCT Number: NCT05836376

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

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.

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Key information

Conditions

Mitral Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mitral valve annuloplasty

Procedure

implantation of a prosthetic ring to treat mitral valve regurgitation

Primary outcomes

  1. Mortality

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Michele De Bonis

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 1, 2023
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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