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Mitral RegurgitationCHOICE-MINCT04688190

CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry

An observational study of Mitral Regurgitation and Mitral Valve Disease, run by Universitätsklinikum Hamburg-Eppendorf at 43 sites in 13 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
1,000 participants
Where
43 sitesin 13 countries
Study dates
1 Nov 2020to 31 Dec 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • age under 18 years

Trial locations and contacts

43 sites in 13 countries. Contact the study team or a site near you to ask about taking part.

Sebastian Ludwig, MD contact

+494074100

se.ludwig@uke.de

Lena Strotmann, MD contact

+4074100

L.Strotmann@uke.de

43 sites in 13 countries

Germany11 sites, 11 recruiting

  • HDZ Bad Oeynhausen

    Bad Oeynhausen

    Tanja Rudolph, MD

    Sabine Bleiziffer, MD

    Recruiting

  • German Heart Center Berlin

    Berlin

    Jörg Kempfert, MD

    Axel Unbehaun, MD

    Recruiting

  • Heart Center Bonn

    Bonn

    Georg Nickenig, MD

    Marcel Weber, MD

    Recruiting

  • University Hospital of Cologne

    Cologne

    Matti Adam, MD

    Recruiting

  • Goethe-Universität - University Hospital Frankfurt

    Frankfurt

    Thomas Walther, MD

    Recruiting

  • University Heart and Vascular Center Hamburg

    Hamburg

    Sebastian Ludwig, MD

    Sebastian Ludwig, MD

    Recruiting

  • University Heart Center Lübeck

    Lübeck

    Christian Frerker, MD, +49 451-500-0, info@uksh.de

    Recruiting

  • Heart Center of the University Medical Center Mainz

    Mainz

    Philipp Lurz, Prof, +49 6131 170, kardiologie@unimedizin-mainz.de

    Recruiting

  • German Heart Centre Munich

    Munich

    Hendrik Ruge, MD

    Rüdiger Lange, MD

    Recruiting

  • LMU Munich

    Munich

    Jörg Hausleiter, MD

    Recruiting

  • University Medical Center Ulm

    Ulm

    Mirjam Keßler, Prof, +49 731-500-0, info@uniklinik-ulm.de

    Recruiting

Other trials in Germany

United States9 sites, 9 recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Tsuyoshi Kaneko, MD

    Pinak Shah, MD

    Recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Michael Reardon, MD

    Recruiting

  • Cedars-Sinai Medical Center, Los Angeles

    Los Angeles, California, 90048

    Raj Makkar, MD

    Sung-Han Yoon, MD

    Recruiting

  • Minneapolis Heart Institute at Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

    Paul Sorajja, MD, +1 612-863-4000, info@allina.com

    Recruiting

  • Morristown Medical Center

    Morristown, New Jersey, 07960

    Philippe Généreux, MD, +1 973-971-5000, philippegenereux@gmail.com

    Recruiting

  • Montefiore Medical Center

    New York, New York, 10461

    Azeem Latib, MD, +1 718-920-4321, mlatib@montefiore.org

    Andrea Scotti, MD, +1 718-920-4321

    Recruiting

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma, 73120

    Naeem Tahirkheli, MD, +1 405-608-3200, ntahirkheli@okheart.com

    Recruiting

  • Tampa General Hospital

    Tampa, Florida, 33606

    Hiram G. Bezerra, MD, +1 813-844-7000, info@tgh.org

    Recruiting

  • Tucson Medical Center

    Tucson, Arizona, 85712

    Thomas E. Waggoner, +1 520-327-5461, info@tmcaz.com

    Recruiting

Other trials in United States

Italy5 sites, 5 recruiting

  • ASST Spedali Civili di Brescia

    Brescia

    Marianna Adamo, MD, +39 030-39951, protocollo@pec.asst-spedalicivili.it

    Recruiting

  • San Raffaele University Hospital

    Milan

    Paolo Denti, MD

    Recruiting

  • IRCCS Humanitas Research Hospital

    Milan, 20089

    Antonio Mangieri, MD, +39 02-8224-1, info@humanitas.it

    Recruiting

  • IRCCS Policlinico San Donato

    Milan

    Andrea Garatti, MD, +39 02-5277-1, info@grupposandonato.it

    Recruiting

  • University Hospital of Pisa

    Pisa

    Cristina Giannini, MD, +39 050-992111, urp@ao-pisa.toscana.it

    Recruiting

Other trials in Italy

France4 sites, 4 recruiting

  • CHU Bordeaux

    Bourdeaux

    Thomas Modine, MD

    Recruiting

  • Lille University Hospital

    Lille

    Augustin Coisne, MD

    Recruiting

  • Civils Hospices of Lyon

    Lyon

    Jean-Francois Obadia, MD

    Recruiting

  • Clinique Pasteur

    Toulouse

    Nicolas Dumonteil, MD

    Recruiting

Other trials in France

Canada3 sites, 3 recruiting

  • Québec Heart and Lung Institute (Laval University)

    Québec, Quebec, G1V 4G5

    Rodés-Cabau Josep, MD, +1 418-656-8711, info@icm.qc.ca

    Recruiting

  • Toronto Heart Center

    Toronto

    Neil Fam, MD

    Recruiting

  • St. Paul's Hospital

    Vancouver

    John G Webb, MD

    Recruiting

Other trials in Canada

Poland2 sites, 2 recruiting

  • Poznan University of Medical Sciences

    Poznan

    Marek Grygier, +48 61-854-6000, info@ump.edu.pl

    Recruiting

  • Warsaw Medicover Hospital

    Warsaw

    Krzysztof Wróbel, +48 22-431-8100, info@medicover.pl

    Recruiting

Other trials in Poland

Switzerland2 sites, 2 recruiting

  • Inselspital Bern

    Bern

    Fabien Praz, MD

    Mirjam Wild, MD

    Recruiting

  • USZ Zurich

    Zurich

    Alberto Pozzoli, MD

    Maurizio Taramasso, MD

    Recruiting

Other trials in Switzerland

United Kingdom2 sites, 2 recruiting

  • Royal Brompton Hospital

    London

    Alison Duncan, MD

    Recruiting

  • St Thomas' Hospital - London

    London

    Simon Redwood, MD

    Omar Chehab, MD

    Recruiting

Other trials in United Kingdom

Australia1 site, 1 recruiting

  • St Vincent's Hospital

    Sydney

    David Muller, MD

    Recruiting

Other trials in Australia

Austria1 site, 1 recruiting

  • Medical University of Vienna

    Vienna

    Martin Andreas, Prof, +43 1-40400-0, info@meduniwien.ac.at

    Recruiting

Other trials in Austria

Denmark1 site, 1 recruiting

  • Rigshospitalet

    Copenhagen

    Lars Sondergaard, MD

    Recruiting

Other trials in Denmark

Greece1 site, 1 recruiting

  • Interbalkan Medical Center

    Thessaloniki

    Vlasis Ninios, MD, +30 2310-400000, info@interbalkan.gr

    Recruiting

Other trials in Greece

Norway1 site, 1 recruiting

  • Rikshospitalet, Oslo University Hospital (OUS)

    Oslo

    Gry Dahle, MD

    Recruiting

Other trials in Norway

About this study

Official title: Choice of Optimal Transcatheter Treatment for Mitral Insufficiency Registry

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.

Medical subject headings
Mitral Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04688190
Study groupRoleWhat they receive
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 therapyPatients with TMVR screening failure, who subsequently underwent conservative or optimal medical therapy. Update: These patients are currently no longer systematically included.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

  2. Freedom from device-related complications

    Measured: 30 days

Secondary outcomes (9)

  1. Combined all-cause mortality or rehospitalization for congestive heart failure

    Measured: 12 months

  2. All-cause mortality

    Measured: 12 months

  3. Cardiovascular mortality

    Measured: 12 months

  4. Rehospitalization for congestive heart failure

    Incidence of new-onset or worsening signs and symptoms of heart failure that required urgent therapy and resulted in hospitalization, e.g. as assessed by patient interviews.

    Measured: 12 months

  5. Combined cardiovascular mortality or rehospitalization for congestive heart failure

    Measured: 12 months

  6. Unplanned mitral valve intervention

    Incidence of unplanned surgical or transcatheter re-intervention, heart transplantation or left ventricular assist device implantation, e.g. as assessed by patient interviews.

    Measured: 12 months

  7. Combined all-cause mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention

    Measured: 12 months

  8. Combined cardiovascular mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention

    Measured: 12 months

  9. New York Heart Association (NYHA) stage III or IV

    Assessment of New York Heart Association (NYHA) classification stage (in- or outpatient) after 12 months follow-up, as assessed by patient interviews.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2020
  2. Study start1 Nov 2020
  3. Primary completion1 Dec 2030 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04688190
Sponsor's protocol ID
CHOICE-MI
Acronym
CHOICE-MI
Status last verified
May 2026
First submitted
18 Dec 2020
Last updated
7 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Strotmann L, Scotti A, Coisne A, Heinze A, Stolz L, von Stein P, Ben Ali W, Succar C, Regazzoli D, Kessler M, Duncan A, Rudolph TK, Heide IV, Schulz C, Koll B, Kalbacher D, Schofer N, Nickenig G, Ruge H, Adam M, Giannini C, de Backer O, Adamo M, Garatti A, Frerker C, Stiermaier T, Dahle G, Taramasso M, Walther T, Kempfert J, Dumonteil N, Obadia JF, Tahirkheli N, Grygier M, Genereux P, Bezerra HG, Wrobel K, Waggoner TE, Andreas M, Redwood S, Tang GHL, Reardon M, Sorajja P, Fam N, Muller DW, Praz F, von Bardeleben RS, Hausleiter J, Mangieri A, Ninios V, Denti P, Rottbauer W, Webb JG, Blankenberg S, Rodes-Cabau J, Latib A, Granada JF, Conradi L, Modine T, Ludwig S; CHOICE-MI Investigators. Clinical Outcomes of Transfemoral Transcatheter Mitral Valve Replacement: Results From the CHOICE-MI Registry. JACC Cardiovasc Interv. 2026 Aug 10;19(15):2080-2094. doi: 10.1016/j.jcin.2026.05.003. Epub 2026 May 20.

    PubMed 42575577

  • 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.

    PubMed 40329826

  • 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.

    PubMed 39243262

  • 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.

    PubMed 37194288

Questions about this trial

What is this clinical trial studying?

An observational study of Mitral Regurgitation and Mitral Valve Disease, run by Universitätsklinikum Hamburg-Eppendorf at 43 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Germany, United States, Italy, France, Canada and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sebastian Ludwig, MD (+494074100, se.ludwig@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mitral insufficiency grade 2+ or more (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04688190, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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