CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry

NCT04688190 | Recruiting

• 1 other identifier: CHOICE-MI
• Study Type: observational
• Target: 1,000
• Locations: 12 countries
• Sites: 42

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

Outcome Measures

Primary Outcomes (2)

• Mitral insufficiency grade 2+ or more

  Mitral insufficiency measured by transthoracic echocardiography. Assessment of MI severity according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease.

  12 months

• Freedom from device-related complications

  30 days

Secondary Outcomes (9)

• Combined all-cause mortality or rehospitalization for congestive heart failure

  12 months

• All-cause mortality

  12 months

• Cardiovascular mortality

  12 months

• Rehospitalization for congestive heart failure

  12 months

• Combined cardiovascular mortality or rehospitalization for congestive heart failure

  12 months

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study aimes to include all patients with significant mitral insufficiency, who underwent screening for possible transcatheter mitral valve implantation (TMVI), irrespective of the subsequent therapy.

You may qualify if:

• 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

You may not qualify if:

• \- age under 18 years

Sponsors & Collaborators

• Montreal Heart Institute: collaborator
• Universitätsklinikum Hamburg-Eppendorf: lead
• University Hospital, Bordeaux: collaborator

Study Sites (43)

Tucson Medical Center

Tucson, Arizona, 85712, United States

RECRUITING

Cedars-Sinai Medical Center, Los Angeles

Los Angeles, California, 90048, United States

RECRUITING

Tampa General Hospital

Tampa, Florida, 33606, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Minneapolis Heart Institute at Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

RECRUITING

Morristown Medical Center

Morristown, New Jersey, 07960, United States

RECRUITING

Montefiore Medical Center

New York, New York, 10461, United States

RECRUITING

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73120, United States

RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

St Vincent's Hospital

Sydney, Australia

RECRUITING

Medical University of Vienna

Vienna, Austria

RECRUITING

Québec Heart and Lung Institute (Laval University)

Québec, Quebec, G1V 4G5, Canada

RECRUITING

Toronto Heart Center

Toronto, Canada

RECRUITING

St. Paul's Hospital

Vancouver, Canada

RECRUITING

Rigshospitalet

Copenhagen, Denmark

RECRUITING

CHU Bordeaux

Bourdeaux, France

RECRUITING

Lille University Hospital

Lille, France

RECRUITING

Civils Hospices of Lyon

Lyon, France

RECRUITING

Clinique Pasteur

Toulouse, France

RECRUITING

HDZ Bad Oeynhausen

Bad Oeynhausen, Germany

RECRUITING

German Heart Center Berlin

Berlin, Germany

RECRUITING

Heart Center Bonn

Bonn, Germany

RECRUITING

University Hospital of Cologne

Cologne, Germany

RECRUITING

Goethe-Universität - University Hospital Frankfurt

Frankfurt, Germany

RECRUITING

University Heart and Vascular Center Hamburg

Hamburg, Germany

RECRUITING

University Heart Center Lübeck

Lübeck, Germany

RECRUITING

Heart Center of the University Medical Center Mainz

Mainz, Germany

RECRUITING

German Heart Centre Munich

Munich, Germany

RECRUITING

LMU Munich

Munich, Germany

RECRUITING

University Medical Center Ulm

Ulm, Germany

RECRUITING

Interbalkan Medical Center

Thessaloniki, Greece

RECRUITING

ASST Spedali Civili di Brescia

Brescia, Italy

RECRUITING

San Raffaele University Hospital

Milan, Italy

RECRUITING

IRCCS Humanitas Research Hospital

Milan, 20089, Italy

RECRUITING

IRCCS Policlinico San Donato

Milan, Italy

RECRUITING

University Hospital of Pisa

Pisa, Italy

RECRUITING

Rikshospitalet, Oslo University Hospital (OUS)

Oslo, Norway

RECRUITING

Poznan University of Medical Sciences

Poznan, Poland

RECRUITING

Warsaw Medicover Hospital

Warsaw, Poland

RECRUITING

Inselspital Bern

Bern, Switzerland

RECRUITING

USZ Zurich

Zurich, Switzerland

RECRUITING

Royal Brompton Hospital

London, United Kingdom

RECRUITING

St Thomas' Hospital - London

London, United Kingdom

RECRUITING

Related Publications (3)

• Ludwig S, Coisne A, Hamzi K, Ben Ali W, Scotti A, Koell B, Duncan A, Makkar R, Akodad M, Bleiziffer S, Nickenig G, Kaneko T, Ruge H, Adam M, Sondergaard L, Dahle G, Taramasso M, Walther T, Kempfert J, Obadia JF, Chehab O, Tang GHL, Goel S, Fam N, Denti P, Praz F, von Bardeleben RS, Hausleiter J, Latib A, Conradi L, Modine T, Pezel T, Granada JF; CHOICE-MI Investigators. Phenotypic clustering analysis of patients rejected for mitral valve interventions: implications for future transcatheter technologies. Eur Heart J Cardiovasc Imaging. 2025 Jul 31;26(8):1452-1463. doi: 10.1093/ehjci/jeaf141.

  PMID: 40329826 DERIVED

• Coisne A, Ludwig S, Scotti A, Ben Ali W, Weimann J, Duncan A, Webb JG, Kalbacher D, Rudolph TK, Nickenig G, Hausleiter J, Ruge H, Adam M, Petronio AS, Dumonteil N, Sondergaard L, Adamo M, Regazzoli D, Garatti A, Schmidt T, Dahle G, Taramasso M, Walther T, Kempfert J, Obadia JF, Redwood S, Tang GHL, Goel S, Fam N, Metra M, Andreas M, Muller DW, Denti P, Praz F, von Bardeleben RS, Leroux L, Latib A, Granada JF, Conradi L, Modine T; CHOICE-MI Investigators. Outcomes Following Transcatheter Mitral Valve Replacement Using Dedicated Devices in Patients With Mitral Annular Calcification. JACC Cardiovasc Interv. 2024 Sep 23;17(18):2141-2153. doi: 10.1016/j.jcin.2024.07.038. Epub 2024 Sep 4.

  PMID: 39243262 DERIVED

• Ludwig S, Conradi L, Cohen DJ, Coisne A, Scotti A, Abraham WT, Ben Ali W, Zhou Z, Li Y, Kar S, Duncan A, Lim DS, Adamo M, Redfors B, Muller DWM, Webb JG, Petronio AS, Ruge H, Nickenig G, Sondergaard L, Adam M, Regazzoli D, Garatti A, Schmidt T, Andreas M, Dahle G, Walther T, Kempfert J, Tang GHL, Redwood S, Taramasso M, Praz F, Fam N, Dumonteil N, Obadia JF, von Bardeleben RS, Rudolph TK, Reardon MJ, Metra M, Denti P, Mack MJ, Hausleiter J, Asch FM, Latib A, Lindenfeld J, Modine T, Stone GW, Granada JF; CHOICE-MI and the COAPT Trial Investigators. Transcatheter Mitral Valve Replacement Versus Medical Therapy for Secondary Mitral Regurgitation: A Propensity Score-Matched Comparison. Circ Cardiovasc Interv. 2023 Jun;16(6):e013045. doi: 10.1161/CIRCINTERVENTIONS.123.013045. Epub 2023 May 16.

  PMID: 37194288 DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Lenard Conradi, MD

  University of Cologne

  PRINCIPAL INVESTIGATOR

• Thomas Modine, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Sebastian Ludwig, MD

  University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

• Juan F Granada, MD

  Cardiovascular Research Foundation, New York, USA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian Ludwig, MD

CONTACT

+494074100; se.ludwig@uke.de

Lena Strotmann, MD

CONTACT

+4074100; L.Strotmann@uke.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sebastian Ludwig, M.D., Principal Investigator

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 29, 2020
• Study Start: November 1, 2020
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

GR (1); PL (2); GB (2); CH (2); IT (5); US (9); NO (1); AU (1); FR (4); DK (1); CA (3); DE (11)