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This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPVR - Main Cohort | Experimental | Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR). |
|
| TPVR - THV Registry | Experimental | Subjects with a previously implanted transcatheter valve in the pulmonic position will undergo TPVR. |
|
| TPVR- S3UR Registry | Experimental | 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/SAPIEN 3 Ultra RESILIA THV | Device | SAPIEN 3/SAPIEN 3 Ultra RESILIA THV in the pulmonic position |
|
| Measure | Description | Time Frame |
|---|---|---|
| THV dysfunction | Defined as a non-hierarchical composite of: RVOT reintervention, Moderate or greater total pulmonary regurgitation (PR) via Transthoracic Echocardiography (TTE), Mean RVOT gradient > 40 mmHg via TTE | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Device Success | Defined as a composite of: 1) Single THV implanted in the desired location, 2) RV-PA peak-to-peak gradient < 35 mmHg post-implantation, 3) Less than moderate PR by discharge TTE (or earliest evaluable TTE), 4) Free of explant at 24 hours post-implantation. | Discharge, expected to be within 1-5 days post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edwards THV Clinical Affairs | Contact | (949) 250-2500 | THV_CT.gov@Edwards.com |
| Name | Affiliation | Role |
|---|---|---|
| D. Scott Lim, MD | University of Virginia Medical Center | Principal Investigator |
| Vasilis Babaliaros, MD | Emory University Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Recruiting | Little Rock | Arkansas | 72202 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36608435 | Background | Lim DS, Kim D, Aboulhosn J, Levi D, Fleming G, Hainstock M, Sommer R, Torres AJ, Zhao Y, Shirali G, Babaliaros V. Congenital Pulmonic Valve Dysfunction Treated With SAPIEN 3 Transcatheter Heart Valve (from the COMPASSION S3 Trial). Am J Cardiol. 2023 Mar 1;190:102-109. doi: 10.1016/j.amjcard.2022.12.010. Epub 2023 Jan 4. | |
| 41884901 |
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| SAPIEN 3 THV | Device | SAPIEN 3 THV in the pulmonic position |
|
| SAPIEN 3 Ultra RESILIA THV | Device | SAPIEN 3 Ultra RESILIA THV in the pulmonic position |
|
| Mean RVOT gradient |
| 6 months |
| Paravalvular and total PR | 6 months |
| RVOT reintervention | 6 months |
| Coronary artery compression requiring intervention | 30 days |
| Major vascular complications | 30 days |
| Life-threatening or disabling bleeding | 30 days |
| THV frame fracture | 6 months |
| Device-related endocarditis | 1 year |
| Death (all-cause, procedural and device-related) | 1 year |
| University of California, Los Angeles |
| Completed |
| Los Angeles |
| California |
| 90095 |
| United States |
| University of California,, San Francisco (UCSF) | Recruiting | San Francisco | California | 94143 | United States |
| Childrens Hospital of Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
| Emory University/Children's Healthcare of Atlanta | Recruiting | Atlanta | Georgia | 30322 | United States |
| University of Kentucky | Withdrawn | Lexington | Kentucky | 40536 | United States |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
| Mayo Clinic Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
| St. Louis Children's Hospital | Recruiting | St Louis | Missouri | 63110 | United States |
| Washington University Barnes- Jewish Medical/ St. Louis Children's Hospital | Completed | St Louis | Missouri | 63110 | United States |
| Columbia University Medical Center/NYPH | Recruiting | New York | New York | 10032 | United States |
| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
| The Lindner Research Center at Christ Hospital | Completed | Cincinnati | Ohio | 45219 | United States |
| Cincinnati Children's Hospital | Recruiting | Cincinnati | Ohio | 45229 | United States |
| Nationwide Children's Hospital | Recruiting | Columbus | Ohio | 43205 | United States |
| Penn Presbyterian Medical Center, University of Pennsylvania/ Children's Hospital of Philadelphia | Completed | Philadelphia | Pennsylvania | 19104 | United States |
| UPMC Children's Hospital of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15224 | United States |
| LeBonheur Children's Hopsital | Recruiting | Memphis | Tennessee | 38103 | United States |
| Medical City Dallas | Recruiting | Dallas | Texas | 75230 | United States |
| Children's Health System of Texas / UT Southwestern Medical Center | Recruiting | Dallas | Texas | 75235 | United States |
| Methodist San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
| Intermountain Heart Institute (IMC) | Recruiting | Murray | Utah | 84107 | United States |
| University of Virginia (UVA) | Recruiting | Charlottesville | Virginia | 22908 | United States |
| University of Washington/Seattle Children's Hospital | Completed | Seattle | Washington | 98195 | United States |
| Hainstock MR, Fleming G, Kim D, Aboulhosn J, Levi D, Krasuski R, Sommer R, Torres AJ, Gray R, Kereiakes D, Leventhal A, Gillespie M, Szeto W, Zajarias A, Shahanavaz S, Steinberg ZL, Jones TK, Mahadevan VS, Moore P, Elmariah S, Shirali G, Li W, Babaliaros V, Lim DS; COMPASSION 3 Trial Executive Committee and Study Investigators. Five-Year Outcomes for Patients With RVOT Dysfunction Treated With the SAPIEN 3 Transcatheter Heart Valve: A Pooled Analysis From the COMPASSION S3 Trial. Circ Cardiovasc Interv. 2026 May;19(5):e016361. doi: 10.1161/CIRCINTERVENTIONS.125.016361. Epub 2026 Mar 26. |
| ID | Term |
|---|---|
| D011665 | Pulmonary Valve Insufficiency |
| D013771 | Tetralogy of Fallot |
| D000082862 | Aortic Valve Disease |
| D018633 | Pulmonary Atresia |
| D011666 | Pulmonary Valve Stenosis |
| D014339 | Truncus Arteriosus, Persistent |
| D014188 | Transposition of Great Vessels |
| 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 |
| D054079 | Vascular Malformations |
| D014694 | Ventricular Outflow Obstruction |
| D001028 | Aortopulmonary Septal Defect |
| D006343 | Heart Septal Defects |
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