NCT03130777 - ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 22, 2017

Primary Completion Date

July 14, 2022

Study Completion Date

June 30, 2032

Conditions

Pulmonary DiseaseTranscatheter Pulmonary Valve Replacement (TPVR)Tetralogy of FallotCongenital Heart DiseasePulmonary Regurgitation

Interventions

DEVICE

Edwards Alterra Adaptive Prestent with SAPIEN 3 THV

The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular RVOTs and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 THV.

Trial Locations (14)

10032

Columbia University Medical Center, New York

19104

Children's Hospital of Philadelphia, Philadelphia

22908

University of Virgina, Charlottesville

30322

Emory University/ Children's Healthcare of Atlanta (CHOA), Atlanta

43205

Nationwide Children's Hospital, Columbus

45229

Cincinnati Children's Hospital, Cincinnati

63110

St. Louis Children's Hospital, St Louis

75235

Children's Health Dallas, Dallas

77030

Texas Children's Hospital, Houston

80045

Children's Hospital Colorado, Aurora

90048

Cedars-Sinai Medical Center, Los Angeles

90095

University of California, Los Angeles, Los Angeles

94122

University of California, San Francisco, San Francisco

98105

Seattle Children's Hospital, Seattle