Recruiting

Transcatheter Edge-to-Edge Repair

Sponsor:

University Hospital of Cologne

Code:

NCT06911099

Conditions

Atrial Functional Mitral Regurgitation

Mitral Insufficiency

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Atrial Functional Mitral Regurgitation

Mitral Insufficiency

Study ID

NCT06911099

Start date

Jan 1, 2010

Status verified date

Apr, 2025

Completion date

Dec 31, 2035

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • age under 18 years
  • known regional wall movement disorders

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Composite of all-cause mortality and heart-failure related rehospitalitzation [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Philipp von Stein, MD

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

Christos Iliadis, MD

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

Locations

Montefiore Medical Center

Recruiting

Bronx, New York, United States

Contacts

Azeem Latib, MD

(718) 920-4212mlatib@montefiore.org

Andrea Scotti, MD

a.scotti@hotmail.com

St. Michael's Hospital

Recruiting

Toronto, Canada

Contacts

Neil Fam, MD

416-864-5939Neil.Fam@unityhealth.to

More Information

Sponsor

University Hospital of Cologne

Last update posted

Apr 6, 2025

Last verified

Apr, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospital of Cologne on 2025-04-06.