MitraClip EXPAND G4 Study

Mitral Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04177394
• Other study ID #: ABT-CIP-10320
• Status: Active, not recruiting
• Start date: January 17, 2020
• Est. completion date: March 2028

Study information

• Verified date: June 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 1064
• Est. completion date: March 2028
• Est. primary completion date: May 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

Device:
• MitraClip G4 System
Percutaneous mitral valve repair using the MitraClip G4 system.

Locations

Country	Name	City	State
Canada	Institut de Cardiologie de Montreal (Montreal Heart Inst.)	Montreal	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
France	CHU Hospital de Pontchaillou	Rennes
France	CHU Rangueil Toulouse	Toulouse
Germany	Universitätsklinikum Freiburg	Bad Krozingen
Germany	Herz-und Diabetes Zentrum NRW	Bad Oeynhausen
Germany	Immanuelklinikum Bernau und Herzzentrum Brandenburg	Bernau
Germany	St.-Johannes-Hospital	Dortmund
Germany	Herzzentrum Dresden GmbH Universitätsklinik	Dresden	Saxony
Germany	Medizinische Einrichtungen der Universität Düsseldorf	Düsseldorf
Germany	Elisabeth-Krankenhaus Essen GmbH	Essen	North Rhin
Germany	Klinikum der Justus-Liebig-Universität	Gießen
Germany	Universitatsmedizin Gottingen	Göttingen
Germany	Katholisches Marienkrankenhaus GmbH	Hamburg
Germany	Klinikum der Ruprecht-Karls-Universität Heidelberg	Heidelberg
Germany	Medizinische Einrichtungen der Universitat zu Koln	Köln
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck	Kiel
Germany	Otto-von-Guericke-Universität Magdeburg	Magdeburg
Germany	UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universitat Mainz	Mainz	Rhinela
Germany	Robert-Bosch-Krankenhaus	Stuttgart
Germany	Universitatsklinikum Ulm	Ulm
Israel	Shaare Zedek Medical Center	Jerusalem
Italy	Presidio Ospedaliero Ferrarotto Alessi	Catania
Italy	Centro Cardiologico Monzino	Milan
Italy	Ospedale San Raffaele- Cardiac	Milano	Lombard
Italy	Policlinico San Donato	Milano	Lombard
Japan	Gifu Prefectural General Medical Center	Gifu-shi	Gifu
Japan	Hyogo Brain & Heart Center	Himeji	Hyogo
Japan	Saiseikai Kumamoto Hospital	Kumamoto-shi	Kumamoto
Japan	Nagoya Heart Center	Nagoya-shi	Aichi
Japan	The Sakakibara Heart Insitute of Okayama	Okayama-shi	Okayama
Japan	Sendai Kosei Hospital	Sendai-shi	Miyagi
Japan	Mitsui Memorial Hospital	Tokyo	Kanto
Japan	Toyama University Hospital	Toyama
Netherlands	Erasmus Mc Rotterdam	Rotterdam
Saudi Arabia	Prince Sultan Cardiac Center - Riyadh	Riyadh
Spain	Hospital de la Santa Creu I Sant Pau	Barcelona
Spain	Hospital Alvaro Cunqueiro Dept of Interventional Cardiology	Vigo
United States	Albany Medical Center	Albany	New York
United States	Austin Heart	Austin	Texas
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Northshore University Health System	Evanston	Illinois
United States	Memorial Hermann Hospital	Houston	Texas
United States	Scripps Health	La Jolla	California
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	Cardiology Associates of Mobile, Inc.	Mobile	Alabama
United States	Intermountain Medical Center	Murray	Utah
United States	NCH Healthcare System	Naples	Florida
United States	St. Thomas Hospital	Nashville	Tennessee
United States	Mount Sinai Hospital	New York	New York
United States	NYU Langone Health	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Cardiology Associates of Fairfield County, PC	Norwalk	Connecticut
United States	Integris Baptist Medical Center	Oklahoma City	Oklahoma
United States	Hudson Valley Cardiovascular Practice, P.C.	Poughkeepsie	New York
United States	University of California - Davis Medical Center	Sacramento	California
United States	Prairie Education & Research	Springfield	Illinois
United States	Los Robles Regional Medical Center	Thousand Oaks	California
United States	Via Christi	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Medical Devices	Abbott

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Israel,  Italy,  Japan,  Netherlands,  Saudi Arabia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	No of participants with APS	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
Other	No of participants with ADS	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
Other	Occurrence of In-hospital Major Adverse Events (MAE)	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
Other	Rate of All Cause Mortality Through 5 years	All Cause Mortality Through 5 years	Through 5 years
Other	Number of Heart Failure Hospitalization through 5 years	Heart Failure Hospitalization through 5 years	Through 5 years
Other	Occurrence of MAE	Occurrence of Major Adverse Events (MAE) as defined in the protocol through 5 years	Through 5 years
Other	Rate of Device Related Complications as defined in the protocol through 5 years	Device Related Complications as defined in the protocol through 5 years	Through 5 years
Other	Percentage of Participants with MR Reduction to =2+ or less at Discharge, 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
Other	Percentage of Participants with MR Reduction to =1+ or less at Discharge, 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
Other	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)	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
Other	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)	Difference Between QOL at 30 days, 1, 2, 3, 4 and 5 year	30 days, 1, 2, 3, 4 and 5 year
Other	Difference Between 6 minutes walk distance (6MWD) at 30 days, 1 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
Primary	Percentage of Participants with MR Reduction to =2+ or less at 30 days	MR Severity of 2+ or less at 30 days	At 30 days
Primary	Occurrence of Major Adverse Events (MAE) 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