MitraClip EXPAND G4 Study

NCT04177394 · tracked via the Priya Life Science Canada tracker

Sponsor

Abbott Medical Devices

Phase

Observational

Started

2020-01-17

Last updated

2025-07-11

Condition(s) studied

Mitral Valve RegurgitationMitral Regurgitation

Investigational drug(s) / intervention(s)

MitraClip G4 System

MitraClip G4 System: Percutaneous mitral valve repair using the MitraClip G4 system.

Study 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

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Subjects scheduled to receive the MitraClip per the current approved indications for use 2. Subjects who give consent for their participation Exclusion Criteria: 1\. Subjects participating in another clinical study that may impact the follow-up or results of this study

Primary outcome measure(s)

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.

Trial sites (63)

Facility	City	Region
University of Alabama at Birmingham	Birmingham	Alabama
Cardiology Associates of Mobile, Inc.	Mobile	Alabama
Arkansas Heart Hospital	Little Rock	Arkansas
Scripps Health	La Jolla	California
University of California - Davis Medical Center	Sacramento	California
Los Robles Regional Medical Center	Thousand Oaks	California
Cardiology Associates of Fairfield County, PC	Norwalk	Connecticut
NCH Healthcare System	Naples	Florida
Northshore University Health System	Evanston	Illinois
Prairie Education & Research	Springfield	Illinois
Via Christi	Wichita	Kansas
Abbott Northwestern Hospital	Minneapolis	Minnesota
Albany Medical Center	Albany	New York
NYU Langone Health	New York	New York
Mount Sinai Hospital	New York	New York
Hudson Valley Cardiovascular Practice, P.C.	Poughkeepsie	New York
Carolinas Medical Center	Charlotte	North Carolina
The Cleveland Clinic Foundation	Cleveland	Ohio
Integris Baptist Medical Center	Oklahoma City	Oklahoma
St. Thomas Hospital	Nashville	Tennessee
Austin Heart	Austin	Texas
Memorial Hermann Hospital	Houston	Texas
Intermountain Medical Center	Murray	Utah
Sentara Norfolk General Hospital	Norfolk	Virginia
St. Paul's Hospital	Vancouver	British Columbia
St. Michael's Hospital	Toronto	Ontario
Institut de Cardiologie de Montreal (Montreal Heart Inst.)	Montreal	Quebec
CHU Hospital de Pontchaillou	Rennes	France
CHU Rangueil Toulouse	Toulouse	France
Universitätsklinikum Schleswig-Holstein	Lübeck	Kiel
Elisabeth-Krankenhaus Essen GmbH	Essen	North Rhin
UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universitat Mainz	Mainz	Rhinela
Herzzentrum Dresden GmbH Universitätsklinik	Dresden	Saxony
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

+ 23 more sites — see the full list on the official registry below.

More Abbott Medical Devices trials in Canada

Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation Active, not recruiting

MitraClip REPAIR MR Study Active, not recruiting

Amplatzer Amulet LAAO vs. NOAC Active, not recruiting

TRILUMINATE Pivotal Trial Active, not recruiting

SyncAV Post-Market Trial Active, not recruiting

Other trials for the same condition

Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation Active, not recruiting

ATLAS (AltaValve) Pivotal Trial Recruiting

MitraClip REPAIR MR Study Active, not recruiting

CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry Recruiting

Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04177394 on ClinicalTrials.gov ↗ ← All trials in Canada