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Active, Not Recruiting

NCT Number: NCT04177394

MitraClip EXPAND G4 Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Mitral Valve Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Regurgitation Mitral Valve Insufficiency

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Paul's Hospital, Vancouver, British Columbia, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

MitraClip G4 System

Device

Percutaneous mitral valve repair using the MitraClip G4 system.

Primary outcomes

  1. Number of Participants With Mitral Valve Regurgitation Severity ≤2+ at 30 Days

    Time frame: At 30 days

    Mitral Valve Regurgitation (MR) Severity of 2+ or less at 30 days

  2. 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.

Other outcomes

  1. Number 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. Echocardiogram (30-day echocardiogram will be used if discharge is unavailable or uninterpretable). Subjects who die or undergo mitral valve surgery before discharge are considered to be an APS failure

  2. Number 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.

  3. 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.

  4. Rate of All Cause Mortality Through 5 Years

    Time frame: Through 5 years

    All Cause Mortality Through 5 years

  5. Number of Heart Failure Hospitalization Through 5 Years

    Time frame: Through 5 years

    Heart Failure Hospitalization through 5 years

  6. Occurrence of MAE

    Time frame: Through 5 years

    Occurrence of Major Adverse Events (MAE) as defined in the protocol through 5 years

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Collaborators

  • Abbott

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2028
First posted
Nov 26, 2019
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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