Harmony TPV Post-Approval Study
Condition(s) studied
Investigational drug(s) / intervention(s)
Harmony TPV System: Harmony Transcatheter Pulmonary Valve (sizes 22 mm and 25 mm) and Harmony Delivery Catheter System (DCS)
Study summary
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.
Eligibility
Primary outcome measure(s)
- Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by: — 6 months
* Mean RVOT gradient as measured by continuous-wave Doppler echocardiography ≤40 mmHg AND * Pulmonary regurgitant fraction as measured by CMR \<20%
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham Hospital | Birmingham | Alabama | |
| Cedars Sinai Medical Center | Los Angeles | California | |
| Children's Hospital Colorado | Aurora | Colorado | |
| St. Joseph Children's Hospital | Tampa | Florida | |
| Advocate Christ Medical Center | Oak Lawn | Illinois | |
| Boston Children's Hospital | Boston | Massachusetts | |
| University of Michigan Health System | Ann Arbor | Michigan | |
| Saint Louis Children's Hospital | St Louis | Missouri | |
| Children's Hospital & Medical Center | Omaha | Nebraska | |
| The Mount Sinai Hospital | New York | New York | |
| Children's Hospital New York - Presbyterian | New York | New York | |
| Atrium Health Levine Children's Hospital | Charlotte | North Carolina | |
| Duke University Medical Center | Durham | North Carolina | |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | |
| Cleveland Clinic | Cleveland | Ohio | |
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | |
| Medical University of South Carolina | Charleston | South Carolina | |
| Medical City Children's Hospital | Dallas | Texas | |
| University of Virginia | Charlottesville | Virginia | |
| University of Alberta Hospital | Edmonton | Alberta |
More Medtronic Cardiovascular trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05077774 on ClinicalTrials.gov ↗ ← All trials in the USA