Harmony TPV Post-Approval Study

Running, not enrolling · Not applicable

Conditions studied: Congenital Heart Disease, Tetrology of Fallot, RVOT Anomaly, Pulmonary Regurgitation

In brief

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.

Key facts

Study ID

NCT05077774

Run by

Medtronic Cardiovascular

People needed

174

Starts

2021-10-25

Expected to finish

2035-03-01

Last updated by the study team

2026-06-02

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham Hospital — Birmingham, Alabama, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• St. Joseph Children's Hospital — Tampa, Florida, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Saint Louis Children's Hospital — St Louis, Missouri, United States
• Children's Hospital & Medical Center — Omaha, Nebraska, United States
• The Mount Sinai Hospital — New York, New York, United States
• Children's Hospital New York - Presbyterian — New York, New York, United States
• Atrium Health Levine Children's Hospital — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Medical City Children's Hospital — Dallas, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• University of Alberta Hospital — Edmonton, Alberta, Canada

Full record on ClinicalTrials.gov

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