ALTERRA Post-Approval Study

Running, not enrolling

Conditions studied: Pulmonary Valve Insufficiency, Complex Congenital Heart Defect, Tetralogy of Fallot, Pulmonary Regurgitation, RVOT Anomaly

In brief

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

Key facts

Study ID

NCT05378386

Run by

Edwards Lifesciences

People needed

150

Starts

2022-05-12

Expected to finish

2035-07-01

Last updated by the study team

2025-11-04

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Native or surgically-repaired RVOT with severe PR
• Clinically indicated for pulmonary valve replacement
• Planned for treatment with the Alterra prestent and SAPIEN 3 THV

You may not qualify if…

• Inability to tolerate an anticoagulation/antiplatelet regimen
• Active bacterial endocarditis or other active infections

Where it is running

• Children's of Alabama — Birmingham, Alabama, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Rady Children's Hospital — San Diego, California, United States
• Stanford University — Stanford, California, United States
• Colorado Children's Hospital — Aurora, Colorado, United States
• UF Health Shands Hospital — Gainesville, Florida, United States
• St. Joseph's Children's Hospital — Tampa, Florida, United States
• Advocate Children's Hospital — Oak Lawn, Illinois, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Columbia University — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Le Bonheur Children's Hospital — Memphis, Tennessee, United States
• Medical City Dallas — Dallas, Texas, United States
• Children's Memorial Hermann Hospital — Houston, Texas, United States
• Texas Children's Hospital — Houston, Texas, United States
• Primary Children's Hospital — Salt Lake City, Utah, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Schneider Children's Medical Center of Israel — Petah Tikva, Israel

Full record on ClinicalTrials.gov

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