Mitral Valve RegurgitationNCT04177394
MitraClip EXPAND G4 Study
An observational study of Mitral Valve Regurgitation and Mitral Regurgitation, run by Abbott Medical Devices at 63 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mitral Valve Regurgitation, Mitral Regurgitation
- What is being tested?
- MitraClip G4 System
- Type of treatment
- Medical device
- How many people
- 1,164 participants
- Where
- 63 sitesin 10 countries
- Study dates
- 17 Jan 2020to Mar 2028
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Subjects scheduled to receive the MitraClip per the current approved indications for use
- Subjects who give consent for their participation
Who cannot join
- 1. Subjects participating in another clinical study that may impact the follow-up or results of this study
Trial locations and contacts
63 sites in 10 countries.
63 sites in 10 countries
United States24 sites
Albany Medical Center
Albany, New York, 12208
Austin Heart
Austin, Texas, 78756
University of Alabama at Birmingham
Birmingham, Alabama, 35249
Carolinas Medical Center
Charlotte, North Carolina, 28203
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Northshore University Health System
Evanston, Illinois, 60201
Memorial Hermann Hospital
Houston, Texas, 77030
Scripps Health
La Jolla, California, 92037
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Cardiology Associates of Mobile, Inc.
Mobile, Alabama, 36608
Intermountain Medical Center
Murray, Utah, 84107
NCH Healthcare System
Naples, Florida, 34102
St. Thomas Hospital
Nashville, Tennessee, 37236
NYU Langone Health
New York, New York, 10016
Mount Sinai Hospital
New York, New York, 10029
Sentara Norfolk General Hospital
Norfolk, Virginia, 23504
Cardiology Associates of Fairfield County, PC
Norwalk, Connecticut, 06851
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112
Hudson Valley Cardiovascular Practice, P.C.
Poughkeepsie, New York, 12601
University of California - Davis Medical Center
Sacramento, California, 95817
Prairie Education & Research
Springfield, Illinois, 62769
Los Robles Regional Medical Center
Thousand Oaks, California, 91360
Via Christi
Wichita, Kansas, 67218
Germany17 sites
Universitätsklinikum Freiburg
Bad Krozingen
Herz-und Diabetes Zentrum NRW
Bad Oeynhausen
Immanuelklinikum Bernau und Herzzentrum Brandenburg
Bernau
Medizinische Einrichtungen der Universitat zu Koln
Cologne
St.-Johannes-Hospital
Dortmund
Herzzentrum Dresden GmbH Universitätsklinik
Dresden, Saxony, 01307
Medizinische Einrichtungen der Universität Düsseldorf
Düsseldorf
Elisabeth-Krankenhaus Essen GmbH
Essen, North Rhin, 45138
Klinikum der Justus-Liebig-Universität
Giessen
Universitatsmedizin Gottingen
Göttingen
Katholisches Marienkrankenhaus GmbH
Hamburg, 22087
Klinikum der Ruprecht-Karls-Universität Heidelberg
Heidelberg
Universitätsklinikum Schleswig-Holstein
Lübeck, Kiel, 24105
Otto-von-Guericke-Universität Magdeburg
Magdeburg
UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universitat Mainz
Mainz, Rhinela, 55131
Robert-Bosch-Krankenhaus
Stuttgart
Universitatsklinikum Ulm
Ulm
Japan8 sites
Gifu Prefectural General Medical Center
Gifu, Gifu, 500-8717
Hyogo Brain & Heart Center
Himeji, Hyōgo, 670-0981
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, 861-4193
Nagoya Heart Center
Nagoya, Aichi-ken, 461-0045
The Sakakibara Heart Insitute of Okayama
Okayama, Okayama-ken, 700-0804
Sendai Kosei Hospital
Sendai, Miyagi, 980-0873
Mitsui Memorial Hospital
Tokyo, Kanto, 101-8643
Toyama University Hospital
Toyama, 930-0194
Italy4 sites
Presidio Ospedaliero Ferrarotto Alessi
Catania
Ospedale San Raffaele- Cardiac
Milan, Lombard, 20132
Policlinico San Donato
Milan, Lombard, 20132
Centro Cardiologico Monzino
Milan
Canada3 sites
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, Quebec, H1T 1C8
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
St. Paul's Hospital
Vancouver, British Columbia, V6Z 2E8
France2 sites
CHU Hospital de Pontchaillou
Rennes
CHU Rangueil Toulouse
Toulouse
Spain2 sites
Hospital de la Santa Creu I Sant Pau
Barcelona
Hospital Alvaro Cunqueiro Dept of Interventional Cardiology
Vigo
About this study
Official title: A Post-Market Study Assessment of the Safety and Performance of the MitraClip G4 System
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.
Read the detailed description
This is a post-market, multi-center, single-arm, prospective study to assess the safety and performance of the next generation MitraClip G4 System. The current protocol describes the design of this post-market study.
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
- Mitral Valve Regurgitation, Mitral Regurgitation
- Being tested
- MitraClip G4 System
- Keywords
- MitraClip, MitraClip G4, Mitral Regurgitation
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitraClip G4 SystemDevice
Percutaneous mitral valve repair using the MitraClip G4 system.
| Study group | Role | What they receive |
|---|---|---|
| MitraClip G4 System | Percutaneous mitral valve repair using the MitraClip G4 system Receives: Device: MitraClip G4 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Mitral Valve Regurgitation Severity ≤2+ at 30 Days
Mitral Valve Regurgitation (MR) Severity of 2+ or less at 30 days
Measured: 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.
Measured: At 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start17 Jan 2020
- Primary completion19 May 2022
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve RegurgitationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Kartik Sundareswaran, PhD, Study director, Abbott Structural Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177394
- Sponsor's protocol ID
- ABT-CIP-10320
- Status last verified
- Jul 2025
- First submitted
- 22 Nov 2019
- Last updated
- 11 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 40713981Morikawa 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.
PubMed 39619400von 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.
PubMed 37877913
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Study Assessment of the Safety and Performance of the MitraClip G4 System
- ClinicalTrials.gov ID
- NCT04177394
- Acronym / sponsor ID
- ABT-CIP-10320
- Conditions
- Mitral Valve Regurgitation, Mitral Regurgitation
- Keywords
- MitraClip, MitraClip G4, Mitral Regurgitation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,164 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Abbott
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 19 May 2022 (actual)
- Study completion
- Mar 2028 (estimated)
- First posted
- 26 Nov 2019 (actual)
- Results
- Posted 20 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a post-market, multi-center, single-arm, prospective study to assess the safety and performance of the next generation MitraClip G4 System. The current protocol describes the design of this post-market study.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MitraClip G4 System | – | Device: MitraClip G4 SystemPercutaneous mitral valve repair using the MitraClip G4 system |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Subjects scheduled to receive the MitraClip per the current approved indications for use
- Subjects who give consent for their participation
Key exclusion criteria (1 listed)
- 1. Subjects participating in another clinical study that may impact the follow-up or results of this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MitraClip G4 SystemPercutaneous mitral valve repair using the MitraClip G4 system. | Device | MitraClip G4 System |
Primary outcome
Number of Participants With Mitral Valve Regurgitation Severity ≤2+ at 30 Days
Time frame: At 30 days
Mitral Valve Regurgitation (MR) Severity of 2+ or less at 30 days
Occurrence of Major Adverse Events (MAE) at 30 Days
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40713981Tang 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.
- Derived from this study: PubMed 39619400Morikawa 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.
- Derived from this study: PubMed 37877913von 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kartik Sundareswaran, PhD study director
Abbott Structural Heart
63 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Regurgitation and Mitral Regurgitation, run by Abbott Medical Devices at 63 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States, Germany, Japan, Italy, Canada and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Mitral Valve Regurgitation Severity ≤2+ at 30 Days (time frame: At 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04177394, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.