Clinical trial NCT06911099: Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation (ATRIAL-MR)
Official title: Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: University Hospital of Cologne
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study aimes to include all patients with clinically significant mitral regurgitation of the atrial functional mitral regurgitation subtype, irrespective of the subsequent therapy.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* age under 18 years
* known regional wall movement disorders

Primary outcomes:
measure: Composite of all-cause mortality and heart-failure related rehospitalitzation
timeFrame: 12 months
Secondary outcomes:
measure: Residual Mitral Regurgitation ≤1+
timeFrame: 12 months
measure: All-cause mortality
timeFrame: 12 months
measure: Cardiovascular mortality
timeFrame: 12 months
measure: Heart failure related rehospitalization
timeFrame: 12 months
measure: Unplanned mitral valve intervention
timeFrame: 12 months
measure: New York Heart Association (NYHA) class III or IV
timeFrame: 12 months
measure: 6 Minute Walking Distance
timeFrame: 12 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Toronto
country: Canada
facility: St. Michael's Hospital
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Nantes
country: France
facility: University Hospital Center of Nantes
city: Munich
country: Germany
facility: LMU Klinikum
state: Bavaria
city: Cologne
country: Germany
facility: University Hospital Cologne
state: NRW
city: Bad Oeynhausen
country: Germany
facility: HDZ Bad Oeynhausen
city: Bonn
country: Germany
facility: Heart Center Bonn
city: Düsseldorf
country: Germany
facility: University Hospital of Düsseldorf
city: Hamburg
country: Germany
facility: University Heart and Vascular Center Hamburg
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein
city: Leipzig
country: Germany
facility: Heart Center Leipzig at University of Leipzig
city: Mainz
country: Germany
facility: Heart Center of the University Medical Center Mainz
city: Ulm
country: Germany
facility: University Heart Center Ulm
city: Brescia
country: Italy
facility: University of Brescia
city: Milan
country: Italy
facility: San Raffaele University Hospital
city: Pisa
country: Italy
facility: University of Pisa
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
city: Cordoba
country: Spain
facility: Reina Sofia University Hospital
city: Leon
country: Spain
facility: University Hospital of León
city: Oviedo
country: Spain
facility: Asturias Central University Hospital
city: Vigo
country: Spain
facility: University Hospital Alvaro Cunqueiro
Study officials:
affiliation: Heart Center, Department III of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany
name: Christos Iliadis, MD
role: PRINCIPAL_INVESTIGATOR
References: