The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

Last updated: September 9, 2025
Sponsor: Medtronic Heart Valves
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Heart Disease

Heart Defect

Congenital Heart Disease

Treatment

Harmony TPV System

Clinical Study ID

NCT02979587
MDT16004CON001
  • All Genders

Study Summary

The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of transcatheter implantation of the Medtronic Harmony TPV.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject has severe pulmonary regurgitation as assessed via echocardiography or CMRdetermined PR fraction >/= 30%

  • Subject has clinical indication for surgical placement of an RV-PA conduit orbioprosthetic pulmonary valve

  • Subject is willing to consent to participate

Exclusion

Exclusion Criteria:

  • Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgicallytreated with an RV-to-PA conduit implant

  • RVOT anatomy or morphology that is unfavorable for device anchoring

  • Positive pregnancy test

  • Life expectancy of less than 1 year

Study Design

Total Participants: 86
Treatment Group(s): 1
Primary Treatment: Harmony TPV System
Phase:
Study Start date:
January 01, 2017
Estimated Completion Date:
February 28, 2031

Study Description

The continued clinical experience addendum is a prospective, multi-center, non-randomized, interventional study to evaluate the safety and effectiveness of the Harmony TPV system. All implanted subjects will receive the Harmony TPV 22 or Harmony mTPV 25 device. This phase allows up to 45 subjects implanted with TPV 22 in the United States and Canada, and up to 84 subjects implanted with mTPV 25 in the United States.

The Post Approval Phase (PAS) addendum is a prospective, multi-center, non-randomized, post-market study to evaluate the safety and effectiveness of the Harmony TPV system in the United States. All implanted subjects have been implanted with the Harmony TPV 22 or Harmony mTPV 25 device during the pivotal or CAS phase of the study. The PAS addendum extends follow-up from five years to ten years for consenting subjects.

Connect with a study center

  • The Hospital for Sick Children (SickKids)

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • Toronto General Hospital

    Toronto, Ontario M5G 2C4
    Canada

    Site Not Available

  • The Hospital for Sick Children (SickKids)

    Toronto 6167865, Ontario 6093943 M5G 1X8
    Canada

    Site Not Available

  • Toronto General Hospital

    Toronto 6167865, Ontario 6093943 M5G 2C4
    Canada

    Site Not Available

  • National Cerebral and Cardiovascular Center

    Suita, Osaka 565-8565
    Japan

    Site Not Available

  • National Cerebral and Cardiovascular Center

    Suita 1851483, Osaka 1853904 565-8565
    Japan

    Site Not Available

  • Sakakibara Heart Institute

    Fuchu, Tokyo 183-0003
    Japan

    Site Not Available

  • Ronald Regan UCLA Medical Center

    Los Angeles, California 90095
    United States

    Site Not Available

  • Stanford University Medical Center

    Palo Alto, California 94304
    United States

    Site Not Available

  • Ronald Regan UCLA Medical Center

    Los Angeles 5368361, California 5332921 90095
    United States

    Site Not Available

  • Stanford University Medical Center

    Palo Alto 5380748, California 5332921 94304
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Yale University

    New Haven 4839366, Connecticut 4831725 06510
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55902
    United States

    Site Not Available

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 55902
    United States

    Site Not Available

  • Nationwide Children's Hospital

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Nationwide Children's Hospital

    Columbus 4509177, Ohio 5165418 43215
    United States

    Site Not Available

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • The Children's Hospital of Philadelphia

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Texas Children's Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Texas Children's Hospital

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Primary Children's Hospital

    Salt Lake City, Utah 84113
    United States

    Site Not Available

  • Primary Children's Hospital

    Salt Lake City 5780993, Utah 5549030 84113
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle 5809844, Washington 5815135 98105
    United States

    Site Not Available

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