at San Francisco, California and other locations
study started
estimated completion
Vaikom Mahadevan



The purpose of this study is to evaluate the hypothesis that valve dysfunction of the Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) System is within the performance goal of 25% 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.

Official Title

COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV


The purpose of this study is to demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3 THV System in subjects with a dysfunctional RVOT conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.


Complex Congenital Heart DefectDysfunctional RVOT Conduits or Previously Implanted Valve in the Pulmonic PositionTetralogy of FallotAortic Valve Defect/Disease Resulting in Ross ProcedurePulmonary AtresiaPulmonary StenosisTruncus ArteriosusTransposition of the Great ArteriesTranscatheter pulmonary valve implantationTranscatheter pulmonary valve replacementTPVTPVRTPVIHeart Defects, CongenitalSAPIEN 3 THV


You can join if…

  • Weight ≥ 20 kg (44 lbs.)
  • Subject presents with at least moderate PR and/or mean RVOT gradient ≥ 35 mmHg.
  • The subject/subject's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

You CAN'T join if...

  • Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 2 weeks after discontinuation of antibiotics)
  • History of or active endocarditis (active treatment with antibiotics) within the past 180 days
  • Leukopenia (WBC < 2000 cells/µL), anemia (Hgb < 7 g/dL), thrombocytopenia (Platelets < 50,000 cells/µL) or any known blood clotting disorder
  • Inappropriate anatomy for femoral introduction and delivery of the SAPIEN 3 THV


  • University of California,, San Francisco (UCSF)
    San FranciscoCalifornia94143United States
  • University of California, Los Angeles
    Los AngelesCalifornia90095United States

Lead Scientist

  • Vaikom Mahadevan
    Dr. Vaikom S Mahadevan joined UCSF from the UK in July 2014 as Director of Structural and Adult Congenital cardiac Interventions and the Wiliam W Parmley Endowed Chair in Cardiology and Associate Professor of Medicine. Following completion of his intital medical training in Stanley Medical College in India Dr. Mahadevan did his higher Internal Medicine and Cardiology training …


in progress, not accepting new patients
Start Date
Completion Date
Edwards Lifesciences
Study Type
Last Updated