The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

Not Recruiting

Trial ID: NCT02979587


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.

Official Title

The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

Stanford Investigator(s)

Michael Ma

Assistant Professor of Cardiothoracic Surgery (Pediatric Cardiac Surgery)


Inclusion Criteria:

   - 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

Exclusion Criteria:

   - 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


device: Harmony TPV System

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305