MitraClip EXPAND G4 Study

Active, not recruiting

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

Inclusion Criteria

Subjects scheduled to receive the MitraClip per the current approved indications for use
Subjects who give consent for their participation

Exclusion Criteria

Subjects participating in another clinical study that may impact the follow-up or results of this study

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

Locations (63): University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Cardiology Associates of Mobile, Inc.
🇺🇸
Mobile, Alabama, United States
Arkansas Heart Hospital
🇺🇸
Little Rock, Arkansas, United States
Scripps Health
🇺🇸
La Jolla, California, United States
University of California - Davis Medical Center
🇺🇸
Sacramento, California, United States
Los Robles Regional Medical Center
🇺🇸
Thousand Oaks, California, United States
Cardiology Associates of Fairfield County, PC
🇺🇸
Norwalk, Connecticut, United States
NCH Healthcare System
🇺🇸
Naples, Florida, United States
Northshore University Health System
🇺🇸
Evanston, Illinois, United States
Prairie Education & Research
🇺🇸
Springfield, Illinois, United States
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University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States