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Harmony TPV Post-Approval Study
The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.
Conditions:
Congenital Heart Disease Tetrology of Fallot RVOT Anomaly Pulmonary Regurgitation
Study Start (Actual) 2021-10-25
Primary Completion (Estimated) 2025-10
Study Completion (Estimated) 2035-03
Enrollment (Estimated) 150
Study Type INTERVENTIONAL
Phase NA
Locations:
📍 Birmingham, Alabama, United States
📍 Phoenix, Arizona, United States
📍 Los Angeles, California, United States
📍 Aurora, Colorado, United States
📍 Tampa, Florida, United States
📍 Oak Lawn, Illinois, United States
📍 Boston, Massachusetts, United States
📍 Ann Arbor, Michigan, United States
📍 Saint Louis, Missouri, United States
📍 Omaha, Nebraska, United States
📍 New York, New York, United States
📍 New York, New York, United States
📍 Charlotte, North Carolina, United States
📍 Durham, North Carolina, United States
📍 Cincinnati, Ohio, United States
📍 Cleveland, Ohio, United States
📍 Pittsburgh, Pennsylvania, United States
📍 Charleston, South Carolina, United States
📍 Dallas, Texas, United States
📍 Charlottesville, Virginia, United States
More locations available...

Eligibility Criteria

Description

    Inclusion Criteria:

    • * Patient eligible to receive the Harmony TPV, meeting the indications for use criteria per current geography-specific device labeling at time of study enrollment
    • * Patient (or patient's legally authorized representative) is willing to consent to participate in the study

    Exclusion Criteria:

    • * Obstruction of the central veins
    • * Planned concomitant branch pulmonary artery stenting at time of implant
    • * Subject is pregnant at time of implant procedure
    • * Patients with previously treated with an RV-PA conduit or previously implanted bioprosthesis
    • * A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year
    • * Planned implantation of the Harmony TPV in the left heart
    • * Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
    • * Pre-existing prosthetic heart valve or prosthetic ring in any position
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted2021-09-30
  • First Submitted that Met QC Criteria2021-10-01
  • First Posted2021-10-14

Study Record Updates

  • Last Update Submitted that Met QC Criteria2024-07-15
  • Last Update Posted2024-07-16
  • Last Verified2024-07
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