Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation (ATRIAL-MR)

Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06911099

Enrollment

1000

Registered

2025-04-04

Start date

2010-01-01

Completion date

2035-12-31

Last updated

2025-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Functional Mitral Regurgitation, Mitral Insufficiency

Keywords

atrial functional mitral regurgitation, AFMR, atrial secondary mitral regurgitation, ASMR, mitral valve transcatheter edge-to-edge repair, M-TEER

Brief summary

This investigator-initiated, multicenter, international, retrospective registry aims to investigate outcomes of patients with atrial functional mitral regurgitation, as treated in clinical routine.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* functional mitral regurgitation * left ventricular ejection fraction ≥50%

Exclusion criteria

* age under 18 years * known regional wall movement disorders

Design outcomes

Primary

Measure	Time frame
Composite of all-cause mortality and heart-failure related rehospitalitzation	12 months

Secondary

Measure	Time frame	Description
All-cause mortality	12 months	—
Cardiovascular mortality	12 months	—
Heart failure related rehospitalization	12 months	Incidence of new-onset or worsening signs and symptoms of heart failure that required urgent therapy and resulted in hospitalization.
Residual Mitral Regurgitation ≤1+	12 months	Rate of patients achieving residual mitral regurgitation ≤1+ measured by transthoracic echocardiography. Assessment of mitral regurgitation severity according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease.
New York Heart Association (NYHA) class III or IV	12 months	Assessment of New York Heart Association (NYHA) classification stage (in- or outpatient), with the minimum of I (no symptoms) and the maximum of IV (dyspnea at rest), with higher values indicating worse functional capacity.
6 Minute Walking Distance	12 months	—
Unplanned mitral valve intervention	12 months	Incidence of unplanned surgical or transcatheter re-intervention, heart transplantation or left ventricular assist device implantation.

Countries

Canada, France, Germany, Italy, Spain, United States

Contacts

Primary ContactPhilipp von Stein, MD

philipp.von-stein@uk-koeln.de646-321-8145

Backup ContactChristos Iliadis, MD

christos.iliadis@uk-koeln.de+49-221-478-32401

Outcome results