Recruiting

Mitral Insufficiency

Sponsor:

Universitätsklinikum Hamburg-Eppendorf

Code:

NCT04688190

Conditions

Mitral Regurgitation

Mitral Valve Disease

Mitral Annular Calcification

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This multinational, investigator-initiated registry aims to investigate clinical outcomes of patients undergoing transcatheter mitral valve replacement (TMVR). The registry primarily focuses on patients treated with TMVR in real-world clinical practice.

Patients evaluated for TMVR but not undergoing the procedure are no longer systematically included. Historical data may include such patients who subsequently underwent alternative treatments, including transcatheter edge-to-edge repair, mitral valve surgery, or medical/conservative therapy.

Conditions

Mitral Regurgitation

Mitral Valve Disease

Mitral Annular Calcification

Study ID

NCT04688190

Start date

Nov 1, 2020

Status verified date

May, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • clinically significant mitral insufficiency
  • patient underwent screening for TMVI
  • echocardiography data at baseline (and after TMVI, E2E and surgery)
  • follow-up of at least 30 days

Exclusion Criteria:

\- age under 18 years

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Transcatheter Mitral Valve Replacement (TMVR)

Patients with successful TMVR screening, who underwent Transcatheter Mitral Valve Replacement subsequently. All devices may be included.

Mitral transcatheter edge-to-edge repair (M-TEER)

Patients with TMVR screening failure, who subsequently underwent interventional mitral valve edge-to-edge repair. Update: These patients are currently no longer systematically included.

Mitral valve surgery (Surgery)

Patients with TMVR screening failure, who subsequently underwent mitral valve surgery (i.e., mitral valve repair or replacement). Update: These patients are currently no longer systematically included.

Medical/conservative therapy

Patients with TMVR screening failure, who subsequently underwent conservative or optimal medical therapy. Update: These patients are currently no longer systematically included.

Primary outcome measure

  • Mitral insufficiency grade 2+ or more [ Time Frame: 12 months ]
  • Freedom from device-related complications [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Sebastian Ludwig, MD

+494074100se.ludwig@uke.de

Lena Strotmann, MD

+4074100L.Strotmann@uke.de

Locations

Tucson Medical Center

Recruiting

Tucson, Arizona, United States, 85712

Contacts

Thomas E. Waggoner

+1 520-327-5461info@tmcaz.com

Cedars-Sinai Medical Center, Los Angeles

Recruiting

Los Angeles, California, United States, 90048

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Contacts

Hiram G. Bezerra, MD

+1 813-844-7000info@tgh.org

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Minneapolis Heart Institute at Abbott Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Paul Sorajja, MD

+1 612-863-4000info@allina.com

Morristown Medical Center

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

Philippe Généreux, MD

+1 973-971-5000philippegenereux@gmail.com

Montefiore Medical Center

Recruiting

New York, New York, United States, 10461

Contacts

Azeem Latib, MD

+1 718-920-4321mlatib@montefiore.org

Andrea Scotti, MD

+1 718-920-4321

Oklahoma Heart Hospital

Recruiting

Oklahoma City, Oklahoma, United States, 73120

Contacts

Naeem Tahirkheli, MD

+1 405-608-3200ntahirkheli@okheart.com

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Québec Heart and Lung Institute (Laval University)

Recruiting

Québec, Quebec, Canada, G1V 4G5

Contacts

Rodés-Cabau Josep, MD

+1 418-656-8711info@icm.qc.ca

Toronto Heart Center

Recruiting

Toronto, Canada

St. Paul's Hospital

Recruiting

Vancouver, Canada

More Information

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Last update posted

May 7, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Universitätsklinikum Hamburg-Eppendorf on 2026-05-07.