ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
AI Description
To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract/pulmonary valve (RVOT/PV) who are indicated for treatment of pulmonary regurgitation (PR).
Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
- Who can join
- child, adult, older adult
- Participants
- 86
- Expected completion
- 2032-06
- Funded by
- industry
Conditions studied
Congenital Heart Disease, Pulmonary Disease, Pulmonary Regurgitation, Tetralogy of Fallot, Transcatheter Pulmonary Valve Replacement (TPVR)
What is being tested
- DEVICE: Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
What it measures
- Main Cohort: THV Dysfunction, Number of patients with THV dysfunction, defined as a non-hierarchical composite of: * RVOT/PV Reintervention * Moderate or greater total Pulmonic Regurgitation via Transthoracic Echocardiography (TTE) * Mean RVOT/PV Gradient \>= 35mmHg via TTE, 6 months
- PDS Registry: Acute PDS Success, Number of patients with acute PDS success, defined as a non-hierarchical composite of: * Single THV implanted in the desired location * Right ventricle to pulmonary artery (RV-PA) peak-to-peak gradient \< 35 mmHg post-THV implantation * Less than moderate total pulmonary regurgitation by discharge TTE (or earliest evaluable TTE) * Free of SAPIEN 3 / Alterra explant at 24 hours post-implantation, 24 hours
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Barnes-Jewish Hospital
Saint Louis, MO
Cedars-Sinai Medical Center
Los Angeles, CA
Children's Hospital of Philadelphia
Philadelphia, PA
Cincinnati Children's Hospital Medical Center
Cincinnati, OH
Emory University Hospital
Atlanta, GA
Nationwide Children's Hospital
Columbus, OH
Ronald Reagan UCLA Medical Center
Los Angeles, CA
Seattle Children’s
Seattle, WA
Texas Children's Hospital
Houston, TX
UCSF Health
San Francisco, CA
University Medical Center
Charlottesville, VA
University of Colorado Hospital
Aurora, CO
William P. Clements Jr. University Hospital
Dallas, TX
Registry entry updated 2025-09-25
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.