A Post-Market Study Assessment of the Safety and Performance of the MitraClip G4 System
Status: Active_not_recruiting
Location: See all (63) locations...
Intervention Type: Device
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• Subjects scheduled to receive the MitraClip per the current approved indications for use
• Subjects who give consent for their participation
Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
Cardiology Associates of Mobile, Inc.
Mobile
Arkansas
Arkansas Heart Hospital
Little Rock
California
Scripps Health
La Jolla
University of California - Davis Medical Center
Sacramento
Los Robles Regional Medical Center
Thousand Oaks
Connecticut
Cardiology Associates of Fairfield County, PC
Norwalk
Florida
NCH Healthcare System
Naples
Illinois
Northshore University Health System
Evanston
Prairie Education & Research
Springfield
Kansas
Via Christi
Wichita
Minnesota
Abbott Northwestern Hospital
Minneapolis
North Carolina
Carolinas Medical Center
Charlotte
New York
Albany Medical Center
Albany
Mount Sinai Hospital
New York
NYU Langone Health
New York
Hudson Valley Cardiovascular Practice, P.C.
Poughkeepsie
Ohio
The Cleveland Clinic Foundation
Cleveland
Oklahoma
Integris Baptist Medical Center
Oklahoma City
Tennessee
St. Thomas Hospital
Nashville
Texas
Austin Heart
Austin
Memorial Hermann Hospital
Houston
Utah
Intermountain Medical Center
Murray
Virginia
Sentara Norfolk General Hospital
Norfolk
Other Locations
Canada
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal
St. Michael's Hospital
Toronto
St. Paul's Hospital
Vancouver
France
CHU Hospital de Pontchaillou
Rennes
CHU Rangueil Toulouse
Toulouse
Germany
Universitätsklinikum Freiburg
Bad Krozingen
Herz-und Diabetes Zentrum NRW
Bad Oeynhausen
Immanuelklinikum Bernau und Herzzentrum Brandenburg
Bernau
St.-Johannes-Hospital
Dortmund
Herzzentrum Dresden GmbH Universitätsklinik
Dresden
Medizinische Einrichtungen der Universität Düsseldorf
Düsseldorf
Elisabeth-Krankenhaus Essen GmbH
Essen
Klinikum der Justus-Liebig-Universität
Gießen
Universitatsmedizin Gottingen
Göttingen
Katholisches Marienkrankenhaus GmbH
Hamburg
Klinikum der Ruprecht-Karls-Universität Heidelberg
Heidelberg
Medizinische Einrichtungen der Universitat zu Koln
Köln
Universitätsklinikum Schleswig-Holstein
Lübeck
Otto-von-Guericke-Universität Magdeburg
Magdeburg
UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universitat Mainz
Mainz
Robert-Bosch-Krankenhaus
Stuttgart
Universitatsklinikum Ulm
Ulm
Israel
Shaare Zedek Medical Center
Jerusalem
Italy
Presidio Ospedaliero Ferrarotto Alessi
Catania
Centro Cardiologico Monzino
Milan
Ospedale San Raffaele- Cardiac
Milano
Policlinico San Donato
Milano
Japan
Gifu Prefectural General Medical Center
Gifu-shi
Hyogo Brain & Heart Center
Himeji
Saiseikai Kumamoto Hospital
Kumamoto-shi
Nagoya Heart Center
Nagoya-shi
The Sakakibara Heart Insitute of Okayama
Okayama-shi
Sendai Kosei Hospital
Sendai-shi
Mitsui Memorial Hospital
Tokyo
Toyama University Hospital
Toyama
Netherlands
Erasmus Mc Rotterdam
Rotterdam
Saudi Arabia
Prince Sultan Cardiac Center - Riyadh
Riyadh
Spain
Hospital de la Santa Creu I Sant Pau
Barcelona
Hospital Alvaro Cunqueiro Dept of Interventional Cardiology
Vigo
Time Frame
Start Date: 2020-01-17
Completion Date: 2028-03
Participants
Target number of participants: 1164
Treatments
MitraClip G4 System
Percutaneous mitral valve repair using the MitraClip G4 system
Authors
Norio Tada, Mustafa Ahmed, Paul Sorajja, Brian Whisenant, Paul Mahoney, Craig Elkins, Samir Kapadia, Dabit Arzamendi, Robert Jumper, Juhana Karha, Saibal Kar, Michael J Rinaldi, Annapoorna Kini, Nilesh Goswami, Mir Wail Hashimi, Roberto Cubeddu, Rajeev Narayan, Mark Ricciardi, Chanderdeep Singh, Christian Butter, Helge Möllmann, Raffi Bekeredjian, Holger Nef, Ralph Stephan von Bardeleben, Juergen Rothe, Guillaume Leurent, Kai Friedrichs, Philip Raake, Stephan Baldus, Thibault Lhermusier, Christian Frerker, Thomas Comberg, Alexander Schmeisser, Thomas Schmitz, Tim Seidler, Ulrich Schafer, Bassem Chehab, Mark Reisman, Jason Rogers, Richard Smalling, Mohammad El-Hajjar, Andrew Morse, Carmelo Grasso, Robert Boone, Anita Asgar, Corrado Tamburino, Tetsuari Onishi, Wolfgang Rottbauer, Federico de Marco, Hiroshi Ueno, Andrew Czarnecki, Masahiko Asami, Junichi Yamaguchi, Masanori Yamamoto, Antonio Bartorelli, Paolo Denti, Patrick Horn, Philipp Lurz, Tomohiro Sakamoto, Neil Fam, Axel Linke
Related Therapeutic Areas
Sponsors
Leads: Abbott Medical Devices
Collaborators: Abbott