Clinical trial NCT04177394: MitraClip EXPAND G4 Study
Official title: A Post-Market Study Assessment of the Safety and Performance of the MitraClip G4 System
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Mitral Valve Regurgitation
Mitral Regurgitation
Keywords: MitraClip
MitraClip G4
Mitral Regurgitation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Abbott
First posted: 2019-11-26
Enrollment: 1164
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Mitral Valve Regurgitation Severity ≤2+ at 30 Days
timeFrame: At 30 days
measure: Occurrence of Major Adverse Events (MAE) at 30 Days
timeFrame: At 30 days
Secondary outcomes:
Other outcomes:
measure: Number of Participants With APS
timeFrame: Up to 10 Days
measure: Number of Participants With ADS
timeFrame: Up to 10 Days
measure: Occurrence of In-hospital Major Adverse Events (MAE)
timeFrame: Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days
measure: Rate of All Cause Mortality Through 5 Years
timeFrame: Through 5 years
measure: Number of Heart Failure Hospitalization Through 5 Years
timeFrame: Through 5 years
measure: Occurrence of MAE
timeFrame: Through 5 years
measure: Rate of Device Related Complications as Defined in the Protocol Through 5 Years
timeFrame: Through 5 years
measure: Percentage of Participants With MR Reduction to ≤2+ or Less at Discharge, 30 Days, 1 and 5 Year
timeFrame: 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
measure: Percentage of Participants With MR Reduction to ≤1+ or Less at Discharge, 30 Days, 1 and 5 Year
timeFrame: 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
measure: 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)
timeFrame: 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
measure: 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)
timeFrame: 30 days, 1, 2, 3, 4 and 5 year
measure: Difference Between 6 Minutes Walk Distance (6MWD) at 30 Days, 1 and 5 Year
timeFrame: 30 days, 1, 2, 3, 4 and 5 year
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Mobile
country: United States
facility: Cardiology Associates of Mobile, Inc.
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: La Jolla
country: United States
facility: Scripps Health
state: California
city: Sacramento
country: United States
facility: University of California - Davis Medical Center
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Regional Medical Center
state: California
city: Norwalk
country: United States
facility: Cardiology Associates of Fairfield County, PC
state: Connecticut
city: Naples
country: United States
facility: NCH Healthcare System
state: Florida
city: Evanston
country: United States
facility: Northshore University Health System
state: Illinois
city: Springfield
country: United States
facility: Prairie Education & Research
state: Illinois
city: Wichita
country: United States
facility: Via Christi
state: Kansas
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Cardiovascular Practice, P.C.
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Baptist Medical Center
state: Oklahoma
city: Nashville
country: United States
facility: St. Thomas Hospital
state: Tennessee
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montreal
country: Canada
facility: Institut de Cardiologie de Montreal (Montreal Heart Inst.)
state: Quebec
city: Rennes
country: France
facility: CHU Hospital de Pontchaillou
city: Toulouse
country: France
facility: CHU Rangueil Toulouse
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Kiel
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus Essen GmbH
state: North Rhin
city: Mainz
country: Germany
facility: UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universitat Mainz
state: Rhinela
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH Universitätsklinik
state: Saxony
city: Bad Krozingen
country: Germany
facility: Universitätsklinikum Freiburg
city: Bad Oeynhausen
country: Germany
facility: Herz-und Diabetes Zentrum NRW
city: Bernau
country: Germany
facility: Immanuelklinikum Bernau und Herzzentrum Brandenburg
city: Dortmund
country: Germany
facility: St.-Johannes-Hospital
city: Düsseldorf
country: Germany
facility: Medizinische Einrichtungen der Universität Düsseldorf
city: Gießen
country: Germany
facility: Klinikum der Justus-Liebig-Universität
city: Göttingen
country: Germany
facility: Universitatsmedizin Gottingen
city: Hamburg
country: Germany
facility: Katholisches Marienkrankenhaus GmbH
city: Heidelberg
country: Germany
facility: Klinikum der Ruprecht-Karls-Universität Heidelberg
city: Köln
country: Germany
facility: Medizinische Einrichtungen der Universitat zu Koln
city: Magdeburg
country: Germany
facility: Otto-von-Guericke-Universität Magdeburg
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus
city: Ulm
country: Germany
facility: Universitatsklinikum Ulm
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Milano
country: Italy
facility: Ospedale San Raffaele- Cardiac
state: Lombard
city: Milano
country: Italy
facility: Policlinico San Donato
state: Lombard
city: Catania
country: Italy
facility: Presidio Ospedaliero Ferrarotto Alessi
city: Milan
country: Italy
facility: Centro Cardiologico Monzino
city: Nagoya-shi
country: Japan
facility: Nagoya Heart Center
state: Aichi
city: Gifu-shi
country: Japan
facility: Gifu Prefectural General Medical Center
state: Gifu
city: Himeji
country: Japan
facility: Hyogo Brain & Heart Center
state: Hyogo
city: Tokyo
country: Japan
facility: Mitsui Memorial Hospital
state: Kanto
city: Kumamoto-shi
country: Japan
facility: Saiseikai Kumamoto Hospital
state: Kumamoto
city: Sendai-shi
country: Japan
facility: Sendai Kosei Hospital
state: Miyagi
city: Okayama-shi
country: Japan
facility: The Sakakibara Heart Insitute of Okayama
state: Okayama
city: Toyama
country: Japan
facility: Toyama University Hospital
city: Rotterdam
country: Netherlands
facility: Erasmus Mc Rotterdam
city: Riyadh
country: Saudi Arabia
facility: Prince Sultan Cardiac Center - Riyadh
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu I Sant Pau
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro Dept of Interventional Cardiology
Study officials:
affiliation: Abbott Structural Heart
name: Kartik Sundareswaran, PhD
role: STUDY_DIRECTOR
References: