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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Harmony TPV System | Other | Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Harmony TPV System | Device | Harmony Transcatheter Pulmonary Valve (sizes 22 mm and 25 mm) and Harmony Delivery Catheter System (DCS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by: |
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects free from all-cause mortality at 6-months | Described by Kaplan-Meier statistics at 6-months. | 6 months |
| Percentage of subjects free from reoperation at 6-months | Described by Kaplan-Meier statistics at 6-months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Balzer, MD | St. Louis Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Hospital | Birmingham | Alabama | 35233 | United States | ||
| Cedars Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37278682 | Derived | Gillespie MJ, McElhinney DB, Jones TK, Levi DS, Asnes J, Gray RG, Cabalka AK, Fujimoto K, Qureshi AM, Justino H, Bergersen L, Benson LN, Haugan D, Boe BA, Cheatham JP. 1-Year Outcomes in a Pooled Cohort of Harmony Transcatheter Pulmonary Valve Clinical Trial Participants. JACC Cardiovasc Interv. 2023 Aug 14;16(15):1917-1928. doi: 10.1016/j.jcin.2023.03.002. Epub 2023 May 17. |
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| 6 months |
| Percentage of subjects free from catheter reintervention at 6-months | Described by Kaplan-Meier statistics at 6-months. | 6 months |
| Percentage of subjects free from TPV dysfunction at 6-months | Described by Kaplan-Meier statistics at 6-months. | 6 months |
| Number and percentage of subjects with procedure success at 30-days | 30-days |
| Number and percentage of subjects with serious device-related adverse events at 6 months | Also described with Kaplan-Meier method for AEs of clinical interest. | 6 months |
| Los Angeles |
| California |
| 90048 |
| United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| St. Joseph Children's Hospital | Tampa | Florida | 33607 | United States |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| Saint Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| Children's Hospital & Medical Center | Omaha | Nebraska | 68114 | United States |
| The Mount Sinai Hospital | New York | New York | 10029 | United States |
| Children's Hospital New York - Presbyterian | New York | New York | 10032 | United States |
| Atrium Health Levine Children's Hospital | Charlotte | North Carolina | 28203 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Medical City Children's Hospital | Dallas | Texas | 75230 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D013771 | Tetralogy of Fallot |
| D011665 | Pulmonary Valve Insufficiency |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006349 | Heart Valve Diseases |
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