©2024 Stanford Medicine
The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study
Not Recruiting
Trial ID: NCT02979587
Purpose
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)
Eligibility
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
Intervention(s):
device: Harmony TPV System
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305