Summary

Location
at Sacramento, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Jason Rogers, MD

Description

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.

Official Title

A Post-Market Study Assessment of the Safety and Performance of the MitraClip G4 System

Details

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 Latin America and Japan 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.

Keywords

Mitral Valve Regurgitation Mitral Regurgitation MitraClip MitraClip G4 Mitral Valve Insufficiency MitraClip G4 System

Eligibility

You can join if…

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

You CAN'T join if...

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

Locations

  • University of California - Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • Los Robles Regional Medical Center accepting new patients
    Thousand Oaks California 91360 United States

Lead Scientist at UC Davis

  • Jason Rogers, MD
    Professor, Cardiovascular Medicine. Authored (or co-authored) 122 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Abbott Medical Devices
Links
Sign up for this study
ID
NCT04177394
Study Type
Observational
Last Updated