CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry
NCT ID: NCT04688190
Last Updated: 2022-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
800 participants
OBSERVATIONAL
2020-11-01
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Transcatheter Mitral Valve Implantation (TMVI)
Patients with successful TMVI screening, who underwent Transcatheter Mitral Valve Implantation subsequently. All devices may be included.
No interventions assigned to this group
Interventional mitral valve edge-to-edge repair (E2E)
Patients with TMVI screening failure, who subsequently underwent interventional mitral valve edge-to-edge repair.
No interventions assigned to this group
Mitral valve surgery (Surgery)
Patients with TMVI screening failure, who subsequently underwent mitral valve surgery (i.e., mitral valve repair or replacement).
No interventions assigned to this group
Medical therapy (OMT)
Patients with TMVI screening failure, who subsequently underwent conservative or optimal medical therapy (OMT).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* patient underwent screening for TMVI
* echocardiography data at baseline (and after TMVI, E2E and surgery)
* follow-up of at least 30 days
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Montreal Heart Institute
OTHER
University Hospital, Bordeaux
OTHER
Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
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Sebastian Ludwig
Sebastian Ludwig, M.D., Principal Investigator
Principal Investigators
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Lenard Conradi, MD
Role: PRINCIPAL_INVESTIGATOR
University Heart and Vascular Center Hamburg
Thomas Modine, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Sebastian Ludwig, MD
Role: PRINCIPAL_INVESTIGATOR
University Heart and Vascular Center Hamburg
Walid Ben Ali, MD
Role: PRINCIPAL_INVESTIGATOR
Montreal Heart Institute
Alison Duncan, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Brompton Hospital, London
Gilbert Tang, MD
Role: PRINCIPAL_INVESTIGATOR
Mount Sinai Medical Center, NYC
Juan F Granada, MD
Role: PRINCIPAL_INVESTIGATOR
Cardiovascular Research Foundation, New York, USA
Locations
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Cedars-Sinai Medical Center, Los Angeles
Los Angeles, California, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Houston Methodist Hospital
Houston, Texas, United States
St Vincent's Hospital
Sydney, , Australia
Toronto Heart Center
Toronto, , Canada
St. Paul's Hospital
Vancouver, , Canada
Rigshospitalet
Copenhagen, , Denmark
CHU Bordeaux
Bourdeaux, , France
Lille University Hospital
Lille, , France
Civils Hospices of Lyon
Lyon, , France
Clinique Pasteur
Toulouse, , France
HDZ Bad Oeynhausen
Bad Oeynhausen, , Germany
German Heart Center Berlin
Berlin, , Germany
Heart Center Bonn
Bonn, , Germany
University Hospital of Cologne
Cologne, , Germany
Goethe-Universität - University Hospital Frankfurt
Frankfurt, , Germany
University Heart and Vascular Center Hamburg
Hamburg, , Germany
Heart Center of the University Medical Center Mainz
Mainz, , Germany
German Heart Centre Munich
Munich, , Germany
LMU Munich
Munich, , Germany
San Raffaele University Hospital
Milan, , Italy
Rikshospitalet, Oslo University Hospital (OUS)
Oslo, , Norway
Inselspital Bern
Bern, , Switzerland
USZ Zurich
Zurich, , Switzerland
Royal Brompton Hospital
London, , United Kingdom
St Thomas' Hospital - London
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Raj Makkar, MD
Role: primary
Sung-Han Yoon, MD
Role: backup
Tsuyoshi Kaneko, MD
Role: primary
Pinak Shah, MD
Role: backup
Michael Reardon, MD
Role: primary
David Muller, MD
Role: primary
Neil Fam, MD
Role: primary
John G Webb, MD
Role: primary
Lars Sondergaard, MD
Role: primary
Thomas Modine, MD
Role: primary
Augustin Coisne, MD
Role: primary
Jean-Francois Obadia, MD
Role: primary
Nicolas Dumonteil, MD
Role: primary
Tanja Rudolph, MD
Role: primary
Sabine Bleiziffer, MD
Role: backup
Jörg Kempfert, MD
Role: primary
Axel Unbehaun, MD
Role: backup
Georg Nickenig, MD
Role: primary
Marcel Weber, MD
Role: backup
Matti Adam, MD
Role: primary
Thomas Walther, MD
Role: primary
Sebastian Ludwig, MD
Role: primary
Ralph Stephan von Bardeleben, MD
Role: primary
Felix Kreidel, MD
Role: backup
Hendrik Ruge, MD
Role: primary
Rüdiger Lange, MD
Role: backup
Jörg Hausleiter, MD
Role: primary
Paolo Denti, MD
Role: primary
Gry Dahle, MD
Role: primary
Fabien Praz, MD
Role: primary
Mirjam Wild, MD
Role: backup
Alberto Pozzoli, MD
Role: primary
Maurizio Taramasso, MD
Role: backup
Alison Duncan, MD
Role: primary
Simon Redwood, MD
Role: primary
Omar Chehab, MD
Role: backup
References
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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.
Other Identifiers
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CHOICE-MI
Identifier Type: -
Identifier Source: org_study_id
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