The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices
NCT ID: NCT03502811
Last Updated: 2022-02-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
1041 participants
OBSERVATIONAL
2018-04-26
2020-12-31
Brief Summary
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Detailed Description
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The MitraClip EXPAND Study will be conducted on commercial MitraClip NTR System and MitraClip XTR System that have received CE Mark and/or FDA approval as required.
Up to 1,000 subjects at a maximum of 60 sites in Europe and the US were initially planned to enroll in the MitraClip EXPAND Study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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MitraClip NTR/XTR System
Percutaneous mitral valve repair using the MitraClip NTR and XTR system
MitraClip NTR/XTR System
Percutaneous mitral valve repair using the MitraClip NTR/XTR system.
Interventions
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MitraClip NTR/XTR System
Percutaneous mitral valve repair using the MitraClip NTR/XTR system.
Eligibility Criteria
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Inclusion Criteria
2. Subjects scheduled to receive the MitraClip per the current approved indications for use
3. Subjects with Symptomatic MR (≥3+)
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Dr. Saibal Kar, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars Sinai, Los Angeles CA
Prof. Francesco Maisano, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Zürich
Locations
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Baptist Medical Center Princeton
Birmingham, Alabama, United States
Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States
Scripps Health
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California - Davis Medical Center
Sacramento, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
JFK Medical Center
West Palm Beach, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Via Christi Regional Medical Center - St. Francis Campus
Kansas City, Kansas, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
St. Luke's Hospital
Kansas City, Missouri, United States
Atlantic Health System - Morristown Memorial Hospital
Morristown, New Jersey, United States
New York-Presbyterian/Columbia University Medical Center
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
New York University Hospital
New York, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Christ Hospital
Cincinnati, Ohio, United States
St. Thomas Hospital
Nashville, Tennessee, United States
Intermountain Medical Center
Murray, Utah, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
München Grosshadern
München, Bavaria, Germany
UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universitat Mainz
Mainz, Rhinela, Germany
Herzzentrum Leipzig GmbH
Leipzig, Saxony, Germany
Kerckhoff-Klinik gGmbH
Bad Nauheim, , Germany
Deutsches Herzzentrum Berlin
Berlin, , Germany
Immanuelklinikum Bernau und Herzzentrum Brandenburg
Bernau, , Germany
Medizinische Einrichtungen der Universitat zu Koln
Cologne, , Germany
St.-Johannes-Hospital
Dortmund, , Germany
Medizinische Einrichtungen der Universität Düsseldorf
Düsseldorf, , Germany
Klinikum der Justus-Liebig-Universität
Giessen, , Germany
Universitatsmedizin Gottingen Georg-August-Universitat
Göttingen, , Germany
Katholisches Marienkrankenhaus GmbH
Hamburg, , Germany
Klinikum der Ruprecht-Karls-Universität Heidelberg
Heidelberg, , Germany
Klinikum Karlsburg der Klinikgruppe Dr. Guth GmbH & Co. KG.
Karlsburg, , Germany
Otto-von-Guericke-Universität Magdeburg
Magdeburg, , Germany
Klinikum Rechts Der Isar der Technischen Universitat Munchen
München, , Germany
Niels-Stensen-Kliniken Marienhospital Osnabrück
Osnabrück, , Germany
Universitatsklinikum Ulm
Ulm, , Germany
Hadassah - Ein Kerem
Jerusalem, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Ospedale San Raffaele- Cardiac
Milan, Lombard, Italy
Ospedale San Raffaele
Milan, Lombard, Italy
Policlinico San Donato
Milan, Lombard, Italy
Presidio Ospedaliero Ferrarotto Alessi
Catania, Sicily, Italy
Centro Cardiologico Monzino
Milan, , Italy
Catharina Ziekenhuis
Eindhoven, , Netherlands
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
Hospital de la Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Puerta de Hierro - Hospital Universitario
Madrid, , Spain
HCU Virgen de la Victoria
Málaga, , Spain
Kantonsspital
Aarau, , Switzerland
Inselspital - University Hospital of Bern
Bern, , Switzerland
Universitaets Spital Zuerich
Zurich, , Switzerland
Royal Brompton Hospital
London, , United Kingdom
Countries
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References
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Kar S, von Bardeleben RS, Rottbauer W, Mahoney P, Price MJ, Grasso C, Williams M, Lurz P, Ahmed M, Hausleiter J, Chehab B, Zamorano JL, Asch FM, Maisano F. Contemporary Outcomes Following Transcatheter Edge-to-Edge Repair: 1-Year Results From the EXPAND Study. JACC Cardiovasc Interv. 2023 Mar 13;16(5):589-602. doi: 10.1016/j.jcin.2023.01.010.
Shuvy M, von Bardeleben RS, Grasso C, Raake P, Lurz P, Zamorano JL, Asch F, Kar S, Maisano F; EXPAND Investigators. Safety and efficacy of MitraClip in acutely ill (NYHA Class IV) patients with mitral regurgitation: Results from the global EXPAND study. ESC Heart Fail. 2023 Apr;10(2):1122-1132. doi: 10.1002/ehf2.14273. Epub 2023 Jan 4.
Sodhi N, Asch FM, Ruf T, Petrescu A, von Bardeleben RS, Lim DS, Maisano F, Kar S, Price MJ. Clinical Outcomes With Transcatheter Edge-to-Edge Repair in Atrial Functional MR From the EXPAND Study. JACC Cardiovasc Interv. 2022 Sep 12;15(17):1723-1730. doi: 10.1016/j.jcin.2022.07.023.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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17-518
Identifier Type: -
Identifier Source: org_study_id
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