The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical 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 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.

Key facts

Study ID

NCT02979587

Run by

Medtronic Heart Valves

People needed

86

Starts

2017-01-01

Expected to finish

2031-02-01

Last updated by the study team

2025-09-19

Who can join

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

You may qualify if…

• Subject has severe pulmonary regurgitation as assessed via echocardiography or CMR determined PR fraction >/= 30%
• Subject has clinical indication for surgical placement of an RV-PA conduit or bioprosthetic pulmonary valve
• Subject is willing to consent to participate

You may not qualify if…

• Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgically treated 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

Where it is running

• Ronald Regan UCLA Medical Center — Los Angeles, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• Yale University — New Haven, Connecticut, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Texas Children's Hospital — Houston, Texas, United States
• Primary Children's Hospital — Salt Lake City, Utah, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• The Hospital for Sick Children (SickKids) — Toronto, Ontario, Canada
• Toronto General Hospital — Toronto, Ontario, Canada
• National Cerebral and Cardiovascular Center — Suita, Osaka, Japan

Full record on ClinicalTrials.gov

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