CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry (CHOICE-MI)

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.

Study Overview

• Status: Recruiting
• Conditions: Mitral Regurgitation; Mitral Valve Disease; Mitral Annular Calcification

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Sebastian Ludwig, MD; Phone Number: +494074100; Email: se.ludwig@uke.de
• Study Contact Backup: Name: Lena Strotmann, MD; Phone Number: +4074100; Email: L.Strotmann@uke.de

Study Locations

• Australia
  • Sydney, Australia
    • Recruiting
    • St Vincent's Hospital
    • Contact: David Muller, MD
• Austria
  • Vienna, Austria
    • Recruiting
    • Medical University of Vienna
    • Contact: Martin Andreas, Prof; Phone Number: +43 1-40400-0; Email: info@meduniwien.ac.at
• Canada
  • Toronto, Canada
    • Recruiting
    • Toronto Heart Center
    • Contact: Neil Fam, MD
  • Vancouver, Canada
    • Recruiting
    • St. Paul's Hospital
    • Contact: John G Webb, MD
  • Quebec
    • Québec, Quebec, Canada, G1V 4G5
      • Recruiting
      • Québec Heart and Lung Institute (Laval University)
      • Contact: Rodés-Cabau Josep, MD; Phone Number: +1 418-656-8711; Email: info@icm.qc.ca
• Denmark
  • Copenhagen, Denmark
    • Recruiting
    • Rigshospitalet
    • Contact: Lars Sondergaard, MD
• France
  • Bourdeaux, France
    • Recruiting
    • CHU Bordeaux
    • Contact: Thomas Modine, MD
  • Lille, France
    • Recruiting
    • Lille University Hospital
    • Contact: Augustin Coisne, MD
  • Lyon, France
    • Recruiting
    • Civils Hospices of Lyon
    • Contact: Jean-Francois Obadia, MD
  • Toulouse, France
    • Recruiting
    • Clinique Pasteur
    • Contact: Nicolas Dumonteil, MD
• Germany
  • Bad Oeynhausen, Germany
    • Recruiting
    • HDZ Bad Oeynhausen
    • Contact: Tanja Rudolph, MD
    • Contact: Sabine Bleiziffer, MD
  • Berlin, Germany
    • Recruiting
    • German Heart Center Berlin
    • Contact: Jörg Kempfert, MD
    • Contact: Axel Unbehaun, MD
  • Bonn, Germany
    • Recruiting
    • Heart Center Bonn
    • Contact: Marcel Weber, MD
    • Contact: Georg Nickenig, MD
  • Cologne, Germany
    • Recruiting
    • University Hospital of Cologne
    • Contact: Matti Adam, MD
  • Frankfurt, Germany
    • Recruiting
    • Goethe-Universität - University Hospital Frankfurt
    • Contact: Thomas Walther, MD
  • Hamburg, Germany
    • Recruiting
    • University Heart and Vascular Center Hamburg
    • Principal Investigator: Sebastian Ludwig, MD
    • Contact: Sebastian Ludwig, MD
  • Lübeck, Germany
    • Recruiting
    • University Heart Center Lübeck
    • Contact: Christian Frerker, MD; Phone Number: +49 451-500-0; Email: info@uksh.de
  • Mainz, Germany
    • Recruiting
    • Heart Center of the University Medical Center Mainz
    • Contact: Philipp Lurz, Prof; Phone Number: +49 6131 170; Email: kardiologie@unimedizin-mainz.de
  • Munich, Germany
    • Recruiting
    • German Heart Centre Munich
    • Contact: Hendrik Ruge, MD
    • Contact: Rüdiger Lange, MD
  • Munich, Germany
    • Recruiting
    • LMU Munich
    • Contact: Jörg Hausleiter, MD
  • Ulm, Germany
    • Recruiting
    • University Medical Center Ulm
    • Contact: Mirjam Keßler, Prof; Phone Number: +49 731-500-0; Email: info@uniklinik-ulm.de
• Greece
  • Thessaloniki, Greece
    • Recruiting
    • Interbalkan Medical Center
    • Contact: Vlasis Ninios, MD; Phone Number: +30 2310-400000; Email: info@interbalkan.gr
• Italy
  • Brescia, Italy
    • Recruiting
    • ASST Spedali Civili di Brescia
    • Contact: Marianna Adamo, MD; Phone Number: +39 030-39951; Email: protocollo@pec.asst-spedalicivili.it
  • Milan, Italy
    • Recruiting
    • IRCCS Policlinico San Donato
    • Contact: Andrea Garatti, MD; Phone Number: +39 02-5277-1; Email: info@grupposandonato.it
  • Milan, Italy
    • Recruiting
    • San Raffaele University Hospital
    • Contact: Paolo Denti, MD
  • Milan, Italy, 20089
    • Recruiting
    • Irccs Humanitas Research Hospital
    • Contact: Antonio Mangieri, MD; Phone Number: +39 02-8224-1; Email: info@humanitas.it
  • Pisa, Italy
    • Recruiting
    • University Hospital of Pisa
    • Contact: Cristina Giannini, MD; Phone Number: +39 050-992111; Email: urp@ao-pisa.toscana.it
• Norway
  • Oslo, Norway
    • Recruiting
    • Rikshospitalet, Oslo University Hospital (OUS)
    • Contact: Gry Dahle, MD
• Poland
  • Poznan, Poland
    • Recruiting
    • Poznan University of Medical Sciences
    • Contact: Marek Grygier; Phone Number: +48 61-854-6000; Email: info@ump.edu.pl
  • Warsaw, Poland
    • Recruiting
    • Warsaw Medicover Hospital
    • Contact: Krzysztof Wróbel; Phone Number: +48 22-431-8100; Email: info@medicover.pl
• Switzerland
  • Bern, Switzerland
    • Recruiting
    • Inselspital Bern
    • Contact: Fabien Praz, MD
    • Contact: Mirjam Wild, MD
  • Zurich, Switzerland
    • Recruiting
    • USZ Zurich
    • Contact: Alberto Pozzoli, MD
    • Contact: Maurizio Taramasso, MD
• United Kingdom
  • London, United Kingdom
    • Recruiting
    • Royal Brompton Hospital
    • Contact: Alison Duncan, MD
  • London, United Kingdom
    • Recruiting
    • St Thomas' Hospital - London
    • Contact: Simon Redwood, MD
    • Contact: Omar Chehab, MD
• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Recruiting
      • Tucson Medical Center
      • Contact: Thomas E. Waggoner; Phone Number: +1 520-327-5461; Email: info@tmcaz.com
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center, Los Angeles
      • Contact: Raj Makkar, MD
      • Contact: Sung-Han Yoon, MD
  • Florida
    • Tampa, Florida, United States, 33606
      • Recruiting
      • Tampa General Hospital
      • Contact: Hiram G. Bezerra, MD; Phone Number: +1 813-844-7000; Email: info@tgh.org
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Tsuyoshi Kaneko, MD
      • Contact: Pinak Shah, MD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Recruiting
      • Minneapolis Heart Institute at Abbott Northwestern Hospital
      • Contact: Paul Sorajja, MD; Phone Number: +1 612-863-4000; Email: info@allina.com
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Recruiting
      • Morristown Medical Center
      • Contact: Philippe Généreux, MD; Phone Number: +1 973-971-5000; Email: philippegenereux@gmail.com
  • New York
    • New York, New York, United States, 10461
      • Recruiting
      • Montefiore Medical Center
      • Contact: Azeem Latib, MD; Phone Number: +1 718-920-4321; Email: mlatib@montefiore.org
      • Contact: Andrea Scotti, MD; Phone Number: +1 718-920-4321
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Recruiting
      • Oklahoma Heart Hospital
      • Contact: Naeem Tahirkheli, MD; Phone Number: +1 405-608-3200; Email: ntahirkheli@okheart.com
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Hospital
      • Contact: Michael Reardon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality		12 months
Cardiovascular mortality		12 months
Combined all-cause mortality or rehospitalization for congestive heart failure		12 months
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.	12 months
Combined cardiovascular mortality or rehospitalization for congestive heart failure		12 months
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.	12 months
Combined all-cause mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention		12 months
Combined cardiovascular mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention		12 months
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.	12 months

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: University Hospital, Bordeaux; Montreal Heart Institute
• Investigators: Principal Investigator: Thomas Modine, MD, University Hospital, Bordeaux; Principal Investigator: Juan F Granada, MD, Cardiovascular Research Foundation, New York, USA; Principal Investigator: Lenard Conradi, MD, University of Cologne; Principal Investigator: Sebastian Ludwig, MD, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: December 25, 2020
• First Posted (Actual): December 29, 2020

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 3, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: CHOICE-MI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No