TVMR With the INNOVALVE System Trial - Early Feasibility Study

Last updated: January 28, 2026
Sponsor: Edwards Lifesciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mitral Valve Regurgitation

Treatment

Innovalve MR system

INNOVALVE system

Clinical Study ID

NCT04919980
2024-13
  • Ages > 18
  • All Genders

Study Summary

Study to evaluate the safety and performance of the INNOVALVE system

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinically significant, symptomatic mitral regurgitation

  • High risk for open-heart surgery

  • Meets anatomical criteria

Exclusion

Exclusion Criteria:

  • Unsuitable anatomy

  • Patient is inoperable

  • EF<25%

Study Design

Total Participants: 65
Treatment Group(s): 2
Primary Treatment: Innovalve MR system
Phase:
Study Start date:
September 01, 2022
Estimated Completion Date:
July 01, 2031

Study Description

The study is a multi-center, First-In-Human, prospective, single arm early feasibility study to evaluate the safety and performance of the INNOVALVE system

Connect with a study center

  • Cedars-Sinai

    Los Angeles, California 90048
    United States

    Site Not Available

  • Cedars-Sinai

    Los Angeles 5368361, California 5332921 90048
    United States

    Active - Recruiting

  • Naples Comprehensive Health

    Naples 4165565, Florida 4155751 34102
    United States

    Active - Recruiting

  • Piedmont Heart Institute

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • Piedmont Heart Institute

    Atlanta 4180439, Georgia 4197000 30309
    United States

    Active - Recruiting

  • Northwestern

    Chicago 4887398, Illinois 4896861 60611
    United States

    Active - Recruiting

  • University of Michigan Hospital and Health Systems

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Michigan Hospital and Health Systems

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 555905
    United States

    Site Not Available

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 555905
    United States

    Active - Recruiting

  • Morristown Medical Center

    Morristown 5101427, New Jersey 5101760 07960
    United States

    Active - Recruiting

  • Cornell

    New York, New York 10021
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • NewYork-Presbyterian / Columbia University

    New York, New York 10032
    United States

    Active - Recruiting

  • Northwell Health

    Manhasset 5125766, New York 5128638 11030
    United States

    Active - Recruiting

  • Cornell

    New York 5128581, New York 5128638 10021
    United States

    Site Not Available

  • NewYork-Presbyterian / Columbia University

    New York 5128581, New York 5128638 10032
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • OhioHealth Research Institute

    Columbus, Ohio 43214
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Active - Recruiting

  • OhioHealth Research Institute

    Columbus 4509177, Ohio 5165418 43214
    United States

    Active - Recruiting

  • Oregon Health & Science Universtiy

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Health & Science Universtiy

    Portland 5746545, Oregon 5744337 97239
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Ascension Saint Thomas

    Nashville 4644585, Tennessee 4662168 37205
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • Swedish Medical Center

    Seattle, Washington 98122
    United States

    Site Not Available

  • Swedish Medical Center

    Seattle 5809844, Washington 5815135 98122
    United States

    Active - Recruiting

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