MitraClip EXPAND G4 Study

June 13, 2022 updated by: Abbott Medical Devices

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1064

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2E8
        • St. Paul's Hospital
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Institut de Cardiologie de Montreal (Montreal Heart Inst.)
  • France
      • Rennes, France
        • CHU Hospital de Pontchaillou
      • Toulouse, France
        • CHU Rangueil Toulouse
  • Germany
      • Bad Krozingen, Germany
        • Universitätsklinikum Freiburg
      • Bad Oeynhausen, Germany
        • Herz-und Diabetes Zentrum NRW
      • Bernau, Germany
        • Immanuelklinikum Bernau und Herzzentrum Brandenburg
      • Dortmund, Germany
        • St.-Johannes-Hospital
      • Düsseldorf, Germany
        • Medizinische Einrichtungen der Universität Düsseldorf
      • Gießen, Germany
        • Klinikum der Justus-Liebig-Universität
      • Göttingen, Germany
        • Universitätsmedizin Göttingen
      • Hamburg, Germany, 22087
        • Katholisches Marienkrankenhaus GmbH
      • Heidelberg, Germany
        • Klinikum der Ruprecht-Karls-Universität Heidelberg
      • Köln, Germany
        • Medizinische Einrichtungen der Universität zu Köln
      • Magdeburg, Germany
        • Otto-von-Guericke-Universität Magdeburg
      • Stuttgart, Germany
        • Robert-Bosch-Krankenhaus
      • Ulm, Germany
        • Universitätsklinikum Ulm
    • Kiel
      • Lübeck, Kiel, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein
    • North Rhin
      • Essen, North Rhin, Germany, 45138
        • Elisabeth-Krankenhaus Essen GmbH
    • Rhinela
      • Mainz, Rhinela, Germany, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Herzzentrum Dresden GmbH Universitätsklinik
  • Israel
      • Jerusalem, Israel
        • Shaare Zedek Medical Center
  • Italy
      • Catania, Italy
        • Presidio Ospedaliero Ferrarotto Alessi
      • Milan, Italy
        • Centro Cardiologico Monzino
    • Lombard
      • Milano, Lombard, Italy, 20132
        • Ospedale San Raffaele- Cardiac
      • Milano, Lombard, Italy, 20132
        • Policlinico San Donato
  • Japan
      • Toyama, Japan, 930-0194
        • Toyama University Hospital
    • Aichi
      • Nagoya-shi, Aichi, Japan, 461-0045
        • Nagoya Heart Center
    • Gifu
      • Gifu-shi, Gifu, Japan, 500-8717
        • Gifu Prefectural General Medical Center
    • Hyogo
      • Himeji, Hyogo, Japan, 670-0981
        • Hyogo Brain & Heart Center
    • Kanto
      • Tokyo, Kanto, Japan, 101-8643
        • Mitsui Memorial Hospital
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan, 861-4193
        • Saiseikai Kumamoto Hospital
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 980-0873
        • Sendai Kosei Hospital
    • Okayama
      • Okayama-shi, Okayama, Japan, 700-0804
        • The Sakakibara Heart Insitute of Okayama
  • Netherlands
      • Rotterdam, Netherlands
        • Erasmus MC Rotterdam
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 1
        • Prince Sultan Cardiac Center - Riyadh
  • Spain
      • Barcelona, Spain
        • Hospital de la Santa Creu i Sant Pau
      • Vigo, Spain
        • Hospital Alvaro Cunqueiro Dept of Interventional Cardiology
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama at Birmingham
      • Mobile, Alabama, United States, 36608
        • Cardiology Associates of Mobile, Inc.
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Heart Hospital
    • California
      • La Jolla, California, United States, 92037
        • Scripps Health
      • Sacramento, California, United States, 95817
        • University of California - Davis Medical Center
      • Thousand Oaks, California, United States, 91360
        • Los Robles Regional Medical Center
    • Connecticut
      • Norwalk, Connecticut, United States, 06851
        • Cardiology Associates of Fairfield County, PC
    • Florida
      • Naples, Florida, United States, 34102
        • NCH Healthcare System
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Northshore University Health System
      • Springfield, Illinois, United States, 62769
        • Prairie Education & Research
    • Kansas
      • Wichita, Kansas, United States, 67218
        • Via Christi
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hospital
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
      • New York, New York, United States, 10016
        • NYU Langone Health
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
      • Poughkeepsie, New York, United States, 12601
        • Hudson Valley Cardiovascular Practice, P.C.
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Integris Baptist Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37236
        • St. Thomas Hospital
    • Texas
      • Austin, Texas, United States, 78756
        • Austin Heart
      • Houston, Texas, United States, 77030
        • Memorial Hermann Hospital
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
    • Virginia
      • Norfolk, Virginia, United States, 23504
        • Sentara Norfolk General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study will include an analysis of all consented subjects who satisfy the inclusion and exclusion criteria and who are treated with the MitraClip G4 System. The study will include approximately 1100 subjects treated with the MitraClip G4 System that have data available for assessment of APS.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MitraClip G4 System
Percutaneous mitral valve repair using the MitraClip G4 system
Device: MitraClip G4 System
Percutaneous mitral valve repair using the MitraClip G4 system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with MR Reduction to ≤2+ or less at 30 days
Time Frame: At 30 days
MR Severity of 2+ or less at 30 days
At 30 days
Occurrence of Major Adverse Events (MAE) at 30 days
Time Frame: 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.
At 30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
No of participants with APS
Time Frame: Up to 10 Days
Acute Procedural Success (APS) defined as successful implantation of the MitraClip device with resulting MR severity of 2+ or less on discharge Echocardiogram.
Up to 10 Days
No of participants with ADS
Time Frame: Up to 10 Days
Acute Device Success defined as successful implant of the MitraClip device without the occurrence of a Device-Related Complication (including device embolization, Single Leaflet Device Attachment (SLDA), bleeding, or perforation) through discharge.
Up to 10 Days
Occurrence of In-hospital Major Adverse Events (MAE)
Time Frame: Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days
In-hospital Major Adverse Events (MAE) defined as the number of MAEs that occur prior to discharge from hospitalization in which MitraClip Procedure was performed.
Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days
Rate of All Cause Mortality Through 5 years
Time Frame: Through 5 years
All Cause Mortality Through 5 years
Through 5 years
Number of Heart Failure Hospitalization through 5 years
Time Frame: Through 5 years
Heart Failure Hospitalization through 5 years
Through 5 years
Occurrence of MAE
Time Frame: Through 5 years
Occurrence of Major Adverse Events (MAE) as defined in the protocol through 5 years
Through 5 years
Rate of Device Related Complications as defined in the protocol through 5 years
Time Frame: Through 5 years
Device Related Complications as defined in the protocol through 5 years
Through 5 years
Percentage of Participants with MR Reduction to ≤2+ or less at Discharge, 30 days, 1 and 5 year
Time Frame: Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days, and at 30 days, 1 and 5 year
MR Reduction to ≤2+ at Discharge, 30 days, 1 and 5 year
Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days, and at 30 days, 1 and 5 year
Percentage of Participants with MR Reduction to ≤1+ or less at Discharge, 30 days, 1 and 5 year
Time Frame: Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days, and at 30 days, 1 and 5 year
MR Reduction to ≤1+ at Discharge, 30 days, 1 and 5 year
Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days, and at 30 days, 1 and 5 year
Difference Between New York Heart Association (NYHA) at Discharge, 30 days, 1, 2, 3, 4 and 5 years, higher class means a worse outcome (Class I to IV)
Time Frame: Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days, and at 30 days, 1, 2, 3, 4 and 5 years
Difference Between NYHA Class at Discharge, 30 days, 1, 2, 3, 4 and 5 years
Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days, and at 30 days, 1, 2, 3, 4 and 5 years
Difference Between Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 30 days, 1, 2, 3, 4 and 5 year, higher score means a better outcome (0-100)
Time Frame: 30 days, 1, 2, 3, 4 and 5 year
Difference Between QOL at 30 days, 1, 2, 3, 4 and 5 year
30 days, 1, 2, 3, 4 and 5 year
Difference Between 6 minutes walk distance (6MWD) at 30 days, 1 and 5 year
Time Frame: 30 days, 1, 2, 3, 4 and 5 year
Difference Between 6MWD at 30 days, 1, 2, 3, 4 and 5 year
30 days, 1, 2, 3, 4 and 5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Collaborators

Abbott

Investigators

  • Study Director: Kartik Sundareswaran, PhD, Abbott Structural Heart

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2020

Primary Completion (Actual)

May 19, 2022

Study Completion (Anticipated)

March 1, 2028

Study Registration Dates

First Submitted

November 22, 2019

First Submitted That Met QC Criteria

November 22, 2019

First Posted (Actual)

November 26, 2019

Study Record Updates

Last Update Posted (Actual)

June 14, 2022

Last Update Submitted That Met QC Criteria

June 13, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABT-CIP-10320

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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