Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention.
This is a single arm, prospective, multicenter post-approval study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPVR | Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAPIEN 3 THV | Device | SAPIEN 3 THV in the pulmonic position |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device Success | Defined as a composite of:
| Discharge, expected to be within 1-5 days post-procedure |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35487 | United States | ||
| Cedars Sinai |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Los Angeles |
| California |
| 90048 |
| United States |
| Children's Hospital of Colorado | Aurora | Colorado | 80045 | United States |
| Advocate Childrens Hospital | Oak Lawn | Illinois | 60453 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Minneapolis Heart | Minneapolis | Minnesota | 55407 | United States |
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| Mount Sinai | New York | New York | 10029 | United States |
| Columbia University Medical Center/NYPH | New York | New York | 10032 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Cincinatti Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43215 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 19146 | United States |
| Dell Children's | Austin | Texas | 78723 | United States |
| Children's Health Dallas | Dallas | Texas | 75235 | United States |
| Primary Children's | Salt Lake City | Utah | 84108 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| ID | Term |
|---|---|
| D011665 | Pulmonary Valve Insufficiency |
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
Not provided
Not provided