Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
1164 participants
OBSERVATIONAL
2020-01-17
2028-03-31
Brief Summary
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Detailed Description
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Up to 1,100 post-market, consented patients will be treated with a MitraClip G4 device according to local guidelines and IFU from the Europe and Middle East, the United States, Canada and Japan, and will be included in the analysis for the MitraClip EXPAND G4 Study. Follow-up echocardiograms will be collected at Discharge, 30 days and 1 year and 5 year at post-procedure visits. Additional clinical follow-up visits will be at 6 months (phone call), 2, 3, 4 year (office visits). Cardiovascular adverse events will be reported through 5 years to confirm safety of the MitraClip G4 System.
During the Phase 1 of the study 100 subjects were enrolled at 15 sites in the United States with the goal of evaluating the early safety and procedural outcomes associated with the MitraClip G4. The follow up duration was 30 days. Phase I was completed August 2020.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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MitraClip G4 System
Percutaneous mitral valve repair using the MitraClip G4 system
MitraClip G4 System
Percutaneous mitral valve repair using the MitraClip G4 system.
Interventions
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MitraClip G4 System
Percutaneous mitral valve repair using the MitraClip G4 system.
Eligibility Criteria
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Inclusion Criteria
2. Subjects who give consent for their participation
Exclusion Criteria
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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Kartik Sundareswaran, PhD
Role: STUDY_DIRECTOR
Abbott Structural Heart
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Cardiology Associates of Mobile, Inc.
Mobile, Alabama, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Scripps Health
La Jolla, California, United States
University of California - Davis Medical Center
Sacramento, California, United States
Los Robles Regional Medical Center
Thousand Oaks, California, United States
Cardiology Associates of Fairfield County, PC
Norwalk, Connecticut, United States
NCH Healthcare System
Naples, Florida, United States
Northshore University Health System
Evanston, Illinois, United States
Prairie Education & Research
Springfield, Illinois, United States
Via Christi
Wichita, Kansas, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Albany Medical Center
Albany, New York, United States
NYU Langone Health
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
Hudson Valley Cardiovascular Practice, P.C.
Poughkeepsie, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States
St. Thomas Hospital
Nashville, Tennessee, United States
Austin Heart
Austin, Texas, United States
Memorial Hermann Hospital
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
St. Paul's Hospital
Vancouver, British Columbia, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, Quebec, Canada
CHU Hospital de Pontchaillou
Rennes, , France
CHU Rangueil Toulouse
Toulouse, , France
Universitätsklinikum Schleswig-Holstein
Lübeck, Kiel, Germany
Elisabeth-Krankenhaus Essen GmbH
Essen, North Rhin, Germany
UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universitat Mainz
Mainz, Rhinela, Germany
Herzzentrum Dresden GmbH Universitätsklinik
Dresden, Saxony, Germany
Universitätsklinikum Freiburg
Bad Krozingen, , Germany
Herz-und Diabetes Zentrum NRW
Bad Oeynhausen, , 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
Göttingen, , Germany
Katholisches Marienkrankenhaus GmbH
Hamburg, , Germany
Klinikum der Ruprecht-Karls-Universität Heidelberg
Heidelberg, , Germany
Otto-von-Guericke-Universität Magdeburg
Magdeburg, , Germany
Robert-Bosch-Krankenhaus
Stuttgart, , Germany
Universitatsklinikum Ulm
Ulm, , Germany
Shaare Zedek Medical Center
Jerusalem, , Israel
Ospedale San Raffaele- Cardiac
Milan, Lombard, Italy
Policlinico San Donato
Milan, Lombard, Italy
Presidio Ospedaliero Ferrarotto Alessi
Catania, , Italy
Centro Cardiologico Monzino
Milan, , Italy
Nagoya Heart Center
Nagoya, Aichi-ken, Japan
Gifu Prefectural General Medical Center
Gifu, Gifu, Japan
Hyogo Brain & Heart Center
Himeji, Hyōgo, Japan
Mitsui Memorial Hospital
Tokyo, Kanto, Japan
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, Japan
Sendai Kosei Hospital
Sendai, Miyagi, Japan
The Sakakibara Heart Insitute of Okayama
Okayama, Okayama-ken, Japan
Toyama University Hospital
Toyama, , Japan
Erasmus Mc Rotterdam
Rotterdam, , Netherlands
Prince Sultan Cardiac Center - Riyadh
Riyadh, , Saudi Arabia
Hospital de la Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Alvaro Cunqueiro Dept of Interventional Cardiology
Vigo, , Spain
Countries
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References
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Tang GHL, Price MJ, Rottbauer W, Mahoney PD, Hausleiter J, Raake PW, Rollefson WA, Lurz P, Denti P, Chehab BK, Dong M, Huang R, Asch FM, Zamorano JL, von Bardeleben RS, Maisano F, Kar S, Rodriguez E. Transcatheter Edge-to-Edge Repair in Secondary Mitral Regurgitation With Extended Non-COAPT-Like Features: From the EXPANDed Studies. JACC Heart Fail. 2025 Sep;13(9):102565. doi: 10.1016/j.jchf.2025.102565. Epub 2025 Jun 27.
Morikawa T, Enta Y, Sakamoto T, Yamamoto M, Ueno H, Yagasaki H, Asch FM, Dong M, Peterman K, Rodriguez E, von Bardeleben RS, Asami M. 1-Year Outcomes of Fourth-Generation Mitral Transcatheter Edge-to-Edge Repair in Japan From the EXPAND G4 Study. JACC Asia. 2024 Sep 24;4(11):810-821. doi: 10.1016/j.jacasi.2024.08.003. eCollection 2024 Nov.
von Bardeleben RS, Mahoney P, Morse MA, Price MJ, Denti P, Maisano F, Rogers JH, Rinaldi M, De Marco F, Rollefson W, Chehab B, Williams M, Leurent G, Asch FM, Rodriguez E. 1-Year Outcomes With Fourth-Generation Mitral Valve Transcatheter Edge-to-Edge Repair From the EXPAND G4 Study. JACC Cardiovasc Interv. 2023 Nov 13;16(21):2600-2610. doi: 10.1016/j.jcin.2023.09.029. Epub 2023 Oct 24.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ABT-CIP-10320
Identifier Type: -
Identifier Source: org_study_id
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