Harmony TPV Post-Approval Study
AI Description
The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.
- Who can join
- child, adult, older adult
- Participants
- 174
- Expected completion
- 2035-03
- 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
- Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by:, * Mean RVOT gradient as measured by continuous-wave Doppler echocardiography ≤40 mmHg AND * Pulmonary regurgitant fraction as measured by CMR \<20%, 6 months
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Advocate Christ Medical Center (Oak Lawn)
Oak Lawn, IL
Atrium Health Carolinas Medical Center
Charlotte, NC
Barnes-Jewish Hospital
Saint Louis, MO
Boston Children's Hospital
Boston, MA
Cedars-Sinai Medical Center
Los Angeles, CA
Cincinnati Children's Hospital Medical Center
Cincinnati, OH
Cleveland Clinic
Cleveland, OH
Duke University Hospital
Durham, NC
Medical City Heart Hospital (Dallas)
Dallas, TX
MUSC Health
Charleston, SC
St. Joseph's Hospital (Tampa)
Tampa, FL
The Mount Sinai Hospital
New York, NY
UAB Hospital
Birmingham, AL
University Medical Center
Charlottesville, VA
University of Colorado Hospital
Aurora, CO
University of Michigan Health System
Ann Arbor, MI
Registry entry updated 2026-06-02
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.