NCT06911099

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
118mo left

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
6 countries

22 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Jan 2010Dec 2035

Study Start

First participant enrolled

January 1, 2010

Completed
15.2 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 4, 2025

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2035

Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

21 years

First QC Date

March 28, 2025

Last Update Submit

April 3, 2025

Conditions

Atrial Functional Mitral RegurgitationMitral Insufficiency

Keywords

atrial functional mitral regurgitationAFMRatrial secondary mitral regurgitationASMRmitral valve transcatheter edge-to-edge repairM-TEER

Outcome Measures

Primary Outcomes (1)

  • Composite of all-cause mortality and heart-failure related rehospitalitzation

    12 months

Secondary Outcomes (7)

  • Residual Mitral Regurgitation ≤1+

    12 months

  • All-cause mortality

    12 months

  • Cardiovascular mortality

    12 months

  • Heart failure related rehospitalization

    12 months

  • Unplanned mitral valve intervention

    12 months

  • +2 more secondary outcomes

Study Arms (3)

Mitral Valve Transcatheter Edge-to-Edge Repair (M-TEER)

Patients who underwent mitral valve transcatheter edge-to-edge repair. All devices may be included.

Guideline Directed Medical Therapy

Patients who underwent conservative management with guideline directed medical therapy.

Transcatheter Mitral Valve Replacement (TMVR)

Patients who underwent transcatheter mitral valve replacement. All devices may be included.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • age under 18 years
  • known regional wall movement disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Montefiore Medical Center

The Bronx, New York, United States

RECRUITING

St. Michael's Hospital

Toronto, Canada

RECRUITING

Bordeaux University Hospital

Bordeaux, France

RECRUITING

University Hospital Center of Nantes

Nantes, France

RECRUITING

LMU Klinikum

Munich, Bavaria, 81377, Germany

RECRUITING

University Hospital Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

HDZ Bad Oeynhausen

Bad Oeynhausen, Germany

RECRUITING

Heart Center Bonn

Bonn, Germany

RECRUITING

University Hospital of Düsseldorf

Düsseldorf, Germany

RECRUITING

University Heart and Vascular Center Hamburg

Hamburg, Germany

RECRUITING

University Hospital Schleswig-Holstein

Kiel, Germany

RECRUITING

Heart Center Leipzig at University of Leipzig

Leipzig, Germany

RECRUITING

Heart Center of the University Medical Center Mainz

Mainz, Germany

RECRUITING

University Heart Center Ulm

Ulm, Germany

RECRUITING

University of Brescia

Brescia, Italy

RECRUITING

San Raffaele University Hospital

Milan, Italy

RECRUITING

University of Pisa

Pisa, Italy

RECRUITING

Hospital Clinic of Barcelona

Barcelona, Spain

RECRUITING

Reina Sofia University Hospital

Córdoba, Spain

RECRUITING

University Hospital of León

León, Spain

RECRUITING

Asturias Central University Hospital

Oviedo, Spain

RECRUITING

University Hospital Alvaro Cunqueiro

Vigo, Spain

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Christos Iliadis, MD

    Heart Center, Department III of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philipp von Stein, MD

CONTACT

646-321-8145philipp.von-stein@uk-koeln.de

Christos Iliadis, MD

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 28, 2025

First Posted

April 4, 2025

Study Start

January 1, 2010

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2035

Last Updated

April 6, 2025

Record last verified: 2025-04

Locations

CA(1)ES(5)US(1)DE(10)IT(3)FR(2)