MitraClip EXPAND G4 Study
- Conditions
- Mitral Valve RegurgitationMitral Regurgitation
- Interventions
- Device: MitraClip G4 System
- Registration Number
- NCT04177394
- Lead Sponsor
- Abbott Medical Devices
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1164
- Subjects scheduled to receive the MitraClip per the current approved indications for use
- Subjects who give consent for their participation
- Subjects participating in another clinical study that may impact the follow-up or results of this study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description MitraClip G4 System MitraClip G4 System Percutaneous mitral valve repair using the MitraClip G4 system
- Primary Outcome Measures
Name Time Method Number of Participants With Mitral Valve Regurgitation Severity ≤2+ at 30 Days At 30 days Mitral Valve Regurgitation (MR) Severity of 2+ or less at 30 days
Occurrence of Major Adverse Events (MAE) at 30 Days 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (63)
NYU Langone Health
🇺🇸New York, New York, United States
Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
St. Thomas Hospital
🇺🇸Nashville, Tennessee, United States
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
🇨🇦Montreal, Quebec, Canada
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
CHU Hospital de Pontchaillou
🇫🇷Rennes, France
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universitat Mainz
🇩🇪Mainz, Rhinela, Germany
St.-Johannes-Hospital
🇩🇪Dortmund, Germany
Klinikum der Ruprecht-Karls-Universität Heidelberg
🇩🇪Heidelberg, Germany
Medizinische Einrichtungen der Universitat zu Koln
🇩🇪Köln, Germany
Otto-von-Guericke-Universität Magdeburg
🇩🇪Magdeburg, Germany
Medizinische Einrichtungen der Universität Düsseldorf
🇩🇪Düsseldorf, Germany
The Sakakibara Heart Insitute of Okayama
🇯🇵Okayama-shi, Okayama, Japan
Toyama University Hospital
🇯🇵Toyama, Japan
Klinikum der Justus-Liebig-Universität
🇩🇪Gießen, Germany
Prince Sultan Cardiac Center - Riyadh
🇸🇦Riyadh, Saudi Arabia
Erasmus Mc Rotterdam
🇳🇱Rotterdam, Netherlands
Hospital de la Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Hospital Alvaro Cunqueiro Dept of Interventional Cardiology
🇪🇸Vigo, Spain
Ospedale San Raffaele- Cardiac
🇮🇹Milano, Lombard, Italy
Policlinico San Donato
🇮🇹Milano, Lombard, Italy
Katholisches Marienkrankenhaus GmbH
🇩🇪Hamburg, Germany
Presidio Ospedaliero Ferrarotto Alessi
🇮🇹Catania, Italy
Centro Cardiologico Monzino
🇮🇹Milan, Italy
Nagoya Heart Center
🇯🇵Nagoya-shi, Aichi, Japan
Gifu Prefectural General Medical Center
🇯🇵Gifu-shi, Gifu, Japan
Saiseikai Kumamoto Hospital
🇯🇵Kumamoto-shi, Kumamoto, Japan
Sendai Kosei Hospital
🇯🇵Sendai-shi, Miyagi, Japan
Universitätsklinikum Schleswig-Holstein
🇩🇪Lübeck, Kiel, Germany
Universitätsklinikum Freiburg
🇩🇪Bad Krozingen, Germany
Immanuelklinikum Bernau und Herzzentrum Brandenburg
🇩🇪Bernau, Germany
Universitatsmedizin Gottingen
🇩🇪Göttingen, Germany
Robert-Bosch-Krankenhaus
🇩🇪Stuttgart, Germany
Universitatsklinikum Ulm
🇩🇪Ulm, Germany
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Elisabeth-Krankenhaus Essen GmbH
🇩🇪Essen, North Rhin, Germany
CHU Rangueil Toulouse
🇫🇷Toulouse, France
Herz-und Diabetes Zentrum NRW
🇩🇪Bad Oeynhausen, Germany
Herzzentrum Dresden GmbH Universitätsklinik
🇩🇪Dresden, Saxony, Germany
Hyogo Brain & Heart Center
🇯🇵Himeji, Hyogo, Japan
Mitsui Memorial Hospital
🇯🇵Tokyo, Kanto, Japan
Cardiology Associates of Mobile, Inc.
🇺🇸Mobile, Alabama, United States
Scripps Health
🇺🇸La Jolla, California, United States
Arkansas Heart Hospital
🇺🇸Little Rock, Arkansas, United States
Los Robles Regional Medical Center
🇺🇸Thousand Oaks, California, United States
Cardiology Associates of Fairfield County, PC
🇺🇸Norwalk, Connecticut, United States
Northshore University Health System
🇺🇸Evanston, Illinois, United States
Prairie Education & Research
🇺🇸Springfield, Illinois, United States
Via Christi
🇺🇸Wichita, Kansas, United States
Albany Medical Center
🇺🇸Albany, 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
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
Austin Heart
🇺🇸Austin, Texas, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Integris Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
University of California - Davis Medical Center
🇺🇸Sacramento, California, United States
NCH Healthcare System
🇺🇸Naples, Florida, United States