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Summary

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

Description

Summary

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 with a clinical indication for intervention.

Official Title

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

Details

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 with a clinical indication for intervention.

Keywords

Complex Congenital Heart Defect Dysfunctional RVOT Conduits Tetralogy of Fallot Aortic Valve Defect/Disease Resulting in Ross Procedure Pulmonary Atresia Pulmonary Stenosis Truncus Arteriosus Transposition of the Great Arteries Transcatheter pulmonary valve implantation Transcatheter pulmonary valve replacement TPV TPVR TPVI

Eligibility

You can join if…

  • Weight ≥ 20 kg (44 lbs.)
  • RVOT conduit with a landing zone diameter ≥ 18 mm and ≤ 29 mm immediately prior to study device insertion
  • 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...

  • RVOT with dysfunctional, previously implanted pulmonary valve (either surgical or transcatheter valve)
  • 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

Locations

  • Ronald Reagan UCLA Medical Center/Mattel Children's Hospital accepting new patients
    Los Angeles, California, 90095, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Edwards Lifesciences
ID
NCT02744677
Phase
Phase 3
Lead Scientist
Vaikom Mahadevan
Study Type
Interventional
Last Updated
April 1, 2017
I’m interested in this study!