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This study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting
This is a single arm, prospective, multicenter post-approval study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPVR | Transcatheter Pulmonary Valve Replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System | Device | The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular right ventricular outflow tracts (RVOTs) and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 transcatheter heart valve (THV). |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Device Success | Acute Device Success, defined as a non-hierarchical composite of:
| 24 hours post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with severe PR who have a native or surgically-repaired RVOT, are clinically indicated for pulmonary valve replacement, and are planned for treatment with the Alterra prestent and SAPIEN 3 THV
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's of Alabama | Birmingham | Alabama | 35233 | United States | ||
| Arkansas Children's Hospital |
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|
| Little Rock |
| Arkansas |
| 72202 |
| United States |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Rady Children's Hospital | San Diego | California | 92123 | United States |
| Stanford University | Stanford | California | 94305 | United States |
| Colorado Children's Hospital | Aurora | Colorado | 80045 | United States |
| UF Health Shands Hospital | Gainesville | Florida | 32669 | United States |
| St. Joseph's Children's Hospital | Tampa | Florida | 33607 | United States |
| Advocate Children's Hospital | Oak Lawn | Illinois | 60453 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Washington University in St. Louis | St Louis | Missouri | 63130 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| Le Bonheur Children's Hospital | Memphis | Tennessee | 38103 | United States |
| Medical City Dallas | Dallas | Texas | 75230 | United States |
| Children's Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Schneider Children's Medical Center of Israel | Petah Tikva | Israel |
| ID | Term |
|---|---|
| D011665 | Pulmonary Valve Insufficiency |
| D013771 | Tetralogy of Fallot |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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