Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

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 100 post-market, consecutive, consented, patients treated with a MitraClip G4 device will be included for analysis into the MitraClip EXPAND G4 study. Clinical follow-up visits for this study is at 30 days. Cardiovascular adverse events will be reported through 30 days to confirm safety of the MitraClip G4 System.

Keywords

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

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Subjects who give consent for study procedure
  2. Subjects eligible to receive the MitraClip per the current approved indications for use
  3. Subjects with Symptomatic MR (≥3+)

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
    Sacramento California 95817 United States
  • Los Robles Regional Medical Center
    Thousand Oaks California 91360 United States

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