Education and Training
The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- device: Harmony TPV System
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
Ages Eligible for Study
N/A - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Not Recruiting