Summary

Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Vaikom Mahadevan

Description

Summary

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.

Official Title

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

Keywords

Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration, 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, Congenital Heart Defects, SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, SAPIEN 3 THV, SAPIEN 3 Ultra RESILIA THV, TPVR - THV Registry, TPVR- S3UR Registry

Eligibility

You can join if…

  1. Weight ≥ 20 kg (44 lbs.)
  2. Dysfunctional RVOT conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention and with a landing zone diameter ≥ 16.5 mm and ≤ 29 mm immediately prior to study device insertion as per the Instructions for Use
  3. Subject presents with at least moderate PR and/or mean RVOT gradient ≥ 35 mmHg.
  4. 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...

  1. Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 2 weeks after discontinuation of antibiotics)
  2. History of or active endocarditis (active treatment with antibiotics) within the past 180 days
  3. Leukopenia, anemia, thrombocytopenia or any known blood clotting disorder
  4. Inappropriate anatomy for femoral introduction and delivery of the study valve
  5. Need for concomitant atrial septal defect or ventricular septal defect closure or other concomitant interventional procedures other than pulmonary artery or branch pulmonary artery stenting or angioplasty
  6. Angiographic evidence of coronary artery compression that would result from transcatheter pulmonic valve implantation (TPVI)
  7. Interventional/surgical procedures within 30 days prior to the TPVI procedure.
  8. Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TPVI procedure.
  9. History of or current intravenous drug use

    10. Major or progressive non-cardiac disease resulting in a life expectancy of less than

    one year

    11. Known hypersensitivity to aspirin or heparin and cannot be treated with other

    antiplatelet and/or antithrombotic medications

    12. Known hypersensitivity to cobalt-chromium, nickel or contrast media that cannot be

    adequately premedicated

    13. Participating in another investigational drug or device study that has not reached its

    primary endpoint.

    14. Female who is lactating or pregnant

Locations

  • UCSF (UCSF) accepting new patients
    San Francisco California 94143 United States
  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Edwards Lifesciences
ID
NCT02744677
Study Type
Interventional
Participants
Expecting 108 study participants
Last Updated