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MitraClip EXPAND G4 Study

Active, not recruiting
Conditions
Mitral Valve Regurgitation
Mitral Regurgitation
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
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Number of Participants With Mitral Valve Regurgitation Severity ≤2+ at 30 DaysAt 30 days

Mitral Valve Regurgitation (MR) Severity of 2+ or less at 30 days

Occurrence of Major Adverse Events (MAE) at 30 DaysAt 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
NameTimeMethod

Trial Locations

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

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