The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study
AI Description
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.
- Who can join
- child, adult, older adult
- Participants
- 86
- Expected completion
- 2031-02
- Funded by
- industry
Conditions studied
Congenital Heart Disease, Pulmonary Regurgitation, RVOT Anomaly, Tetrology of Fallot
What is being tested
- DEVICE: Harmony TPV System
What it measures
- Freedom From Procedure- or Device-related Mortality at 30 Days., The primary safety endpoint is point estimate of freedom from procedure or device-related mortality rate at 30 days post procedure., 30 days
- Number of Participants With Acceptable Hemodynamic Function Composite at 6 Months, Defined as: * Mean RVOT gradient as measured by continuous-wave Doppler ≤40 mmHg -AND- * Pulmonary regurgitant fraction as measured by magnetic resonance imaging \<20%, 6 months
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Children's Hospital of Philadelphia
Philadelphia, PA
Mayo Clinic (Rochester, Minnesota)
Rochester, MN
Nationwide Children's Hospital
Columbus, OH
Ronald Reagan UCLA Medical Center
Los Angeles, CA
Seattle Children’s
Seattle, WA
Stanford Health Care
Stanford, CA
Texas Children's Hospital
Houston, TX
University of Utah Health
Salt Lake City, UT
Yale New Haven Hospital
New Haven, CT
Registry entry updated 2025-09-19
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.