ALTERRA Post-Approval Study
AI Description
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
- Who can join
- child, adult, older adult
- Participants
- 150
- Expected completion
- 2035-07
- Funded by
- industry
Conditions studied
Complex Congenital Heart Defect, Pulmonary Regurgitation, Pulmonary Valve Insufficiency, RVOT Anomaly, Tetralogy of Fallot
What is being tested
- DEVICE: Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System
What it measures
- Acute Device Success, Acute Device Success, defined as a non-hierarchical composite of: * Single Alterra deployed in the desired location * Single THV implanted in the desired location within Alterra * Right ventricle-pulmonary artery peak-to-peak gradient \< 35 mmHg post-THV implantation * Less than moderate total pulmonary regurgitation (PR) by discharge transthoracic echocardiogram * Free of Alterra/SAPIEN 3 explant at 24 hours post-implantation, 24 hours post-procedure
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Advocate Christ Medical Center (Oak Lawn)
Oak Lawn, IL
Arkansas Children’s Hospital
Little Rock, AR
Boston Children's Hospital
Boston, MA
Cedars-Sinai Medical Center
Los Angeles, CA
Cincinnati Children's Hospital Medical Center
Cincinnati, OH
Duke University Hospital
Durham, NC
Medical City Heart Hospital (Dallas)
Dallas, TX
Memorial Hermann-Texas Medical Center
Houston, TX
Nationwide Children's Hospital
Columbus, OH
Rady Children's Hospital-San Diego
San Diego, CA
Seattle Children’s
Seattle, WA
St. Joseph's Hospital (Tampa)
Tampa, FL
Stanford Health Care
Stanford, CA
Texas Children's Hospital
Houston, TX
The Mount Sinai Hospital
New York, NY
UAB Hospital
Birmingham, AL
UF Health Shands Hospital
Gainesville, FL
University of Colorado Hospital
Aurora, CO
University of Utah Health
Salt Lake City, UT
Registry entry updated 2025-11-04
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.