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Study identifier: NCT02744677 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction

Condition: Complex Congenital Heart Defect · Dysfunctional RVOT Conduit · Pulmonary Valve Insufficiency  ·  Sponsor: Edwards Lifesciences

PhaseNA
Planned participants108
Who can joinAll sexes, N/A to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Edwards THV Clinical Affairs  ·  (949) 250-2500  ·  THV_CT.gov@Edwards.com

Always discuss trial participation with your own doctor first.

Locations (27)

University of Alabama at BirminghamBirmingham, Alabama, United StatesRecruiting
Arkansas Children's HospitalLittle Rock, Arkansas, United StatesRecruiting
University of California, Los AngelesLos Angeles, California, United StatesCompleted
University of California,, San Francisco (UCSF)San Francisco, California, United StatesRecruiting
Childrens Hospital of ColoradoAurora, Colorado, United StatesRecruiting
Emory University/Children's Healthcare of AtlantaAtlanta, Georgia, United StatesRecruiting
University of KentuckyLexington, Kentucky, United StatesWithdrawn
Massachusetts General HospitalBoston, Massachusetts, United StatesRecruiting
Boston Children's HospitalBoston, Massachusetts, United StatesRecruiting
Mayo Clinic RochesterRochester, Minnesota, United StatesRecruiting
St. Louis Children's HospitalSt Louis, Missouri, United StatesRecruiting
Washington University Barnes- Jewish Medical/ St. Louis Children's HospitalSt Louis, Missouri, United StatesCompleted

+ 15 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT02744677