MitraClip EXPAND G4 Study
A Post-Market Study Assessment of the Safety and Performance of the MitraClip G4 System
1 other identifier
observational
1,164
10 countries
63
Brief Summary
This primary objective of the EXPAND G4 study is to confirm the safety and performance of the MitraClip G4 System in a post-market setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2020
Longer than P75 for all trials
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2019
CompletedFirst Posted
Study publicly available on registry
November 26, 2019
CompletedStudy Start
First participant enrolled
January 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 19, 2022
CompletedResults Posted
Study results publicly available
January 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
ExpectedJuly 11, 2025
July 1, 2025
2.3 years
November 22, 2019
May 17, 2023
July 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Mitral Valve Regurgitation Severity ≤2+ at 30 Days
Mitral Valve Regurgitation (MR) Severity of 2+ or less at 30 days
At 30 days
Occurrence of Major Adverse Events (MAE) at 30 Days
MAE is defined as a composite of all-cause Death, Myocardial Infarction, Stroke, or non-elective Cardiovascular (CV) surgery for device related complications.
At 30 days
Other Outcomes (12)
Number of Participants With APS
Up to 10 Days
Number of Participants With ADS
Up to 10 Days
Occurrence of In-hospital Major Adverse Events (MAE)
Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days
- +9 more other outcomes
Study Arms (1)
MitraClip G4 System
Percutaneous mitral valve repair using the MitraClip G4 system
Interventions
Percutaneous mitral valve repair using the MitraClip G4 system.
Eligibility Criteria
This study will include an analysis of all consented subjects who satisfy the inclusion and exclusion criteria and who are treated with the MitraClip G4 System. The study will include approximately 1100 subjects treated with the MitraClip G4 System that have data available for assessment of APS.
You may qualify if:
- Subjects scheduled to receive the MitraClip per the current approved indications for use
- Subjects who give consent for their participation
You may not qualify if:
- \. Subjects participating in another clinical study that may impact the follow-up or results of this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Medical Deviceslead
- Abbottcollaborator
Study Sites (63)
University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
Cardiology Associates of Mobile, Inc.
Mobile, Alabama, 36608, United States
Arkansas Heart Hospital
Little Rock, Arkansas, 72211, United States
Scripps Health
La Jolla, California, 92037, United States
University of California - Davis Medical Center
Sacramento, California, 95817, United States
Los Robles Regional Medical Center
Thousand Oaks, California, 91360, United States
Cardiology Associates of Fairfield County, PC
Norwalk, Connecticut, 06851, United States
NCH Healthcare System
Naples, Florida, 34102, United States
Northshore University Health System
Evanston, Illinois, 60201, United States
Prairie Education & Research
Springfield, Illinois, 62769, United States
Via Christi
Wichita, Kansas, 67218, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Albany Medical Center
Albany, New York, 12208, United States
NYU Langone Health
New York, New York, 10016, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Hudson Valley Cardiovascular Practice, P.C.
Poughkeepsie, New York, 12601, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112, United States
St. Thomas Hospital
Nashville, Tennessee, 37236, United States
Austin Heart
Austin, Texas, 78756, United States
Memorial Hermann Hospital
Houston, Texas, 77030, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23504, United States
St. Paul's Hospital
Vancouver, British Columbia, V6Z 2E8, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, Quebec, H1T 1C8, Canada
CHU Hospital de Pontchaillou
Rennes, France
CHU Rangueil Toulouse
Toulouse, France
Universitätsklinikum Schleswig-Holstein
Lübeck, Kiel, 24105, Germany
Elisabeth-Krankenhaus Essen GmbH
Essen, North Rhin, 45138, Germany
UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universitat Mainz
Mainz, Rhinela, 55131, Germany
Herzzentrum Dresden GmbH Universitätsklinik
Dresden, Saxony, 01307, 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, 22087, 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, 20132, Italy
Policlinico San Donato
Milan, Lombard, 20132, Italy
Presidio Ospedaliero Ferrarotto Alessi
Catania, Italy
Centro Cardiologico Monzino
Milan, Italy
Nagoya Heart Center
Nagoya, Aichi-ken, 461-0045, Japan
Gifu Prefectural General Medical Center
Gifu, Gifu, 500-8717, Japan
Hyogo Brain & Heart Center
Himeji, Hyōgo, 670-0981, Japan
Mitsui Memorial Hospital
Tokyo, Kanto, 101-8643, Japan
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, 861-4193, Japan
Sendai Kosei Hospital
Sendai, Miyagi, 980-0873, Japan
The Sakakibara Heart Insitute of Okayama
Okayama, Okayama-ken, 700-0804, Japan
Toyama University Hospital
Toyama, 930-0194, Japan
Erasmus Mc Rotterdam
Rotterdam, Netherlands
Prince Sultan Cardiac Center - Riyadh
Riyadh, 1, Saudi Arabia
Hospital de la Santa Creu I Sant Pau
Barcelona, Spain
Hospital Alvaro Cunqueiro Dept of Interventional Cardiology
Vigo, Spain
Related Publications (3)
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.
PMID: 40713981DERIVEDMorikawa 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.
PMID: 39619400DERIVEDvon 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.
PMID: 37877913DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Melody Dong
- Organization
- Abbott
Study Officials
- STUDY DIRECTOR
Kartik Sundareswaran, PhD
Abbott Structural Heart
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2019
First Posted
November 26, 2019
Study Start
January 17, 2020
Primary Completion
May 19, 2022
Study Completion (Estimated)
March 1, 2028
Last Updated
July 11, 2025
Results First Posted
January 20, 2025
Record last verified: 2025-07