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Purpose

This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) System 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.

Conditions

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  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.

Exclusion Criteria

  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 SAPIEN 3 THV 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. Emergency 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. Currently participating in an investigational drug or another device study. 14. Positive urine or serum pregnancy test in female subjects of child-bearing potential

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
TPVR - Main Cohort
Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).
  • Device: SAPIEN 3 THV
    SAPIEN 3 THV in the pulmonic position
Experimental
TPVR - THV Registry
Subjects with a previously implanted transcatheter valve in the pulmonic position will undergo TPVR.
  • Device: SAPIEN 3 THV
    SAPIEN 3 THV in the pulmonic position

Recruiting Locations

University of California, Los Angeles
Los Angeles, California 90095

University of California,, San Francisco (UCSF)
San Francisco, California 94143

Emory University/Children's Healthcare of Atlanta
Atlanta, Georgia 30322

Columbia University Medical Center/NYPH
New York, New York 10032

Duke University Medical Center
Durham, North Carolina 27710

The Lindner Research Center at Christ Hospital
Cincinnati, Ohio 45219

Penn Presbyterian Medical Center, University of Pennsylvania/ Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104

Intermountain Heart Institute (IMC)
Murray, Utah 84107

University of Virginia (UVA)
Charlottesville, Virginia 22908

University of Washington/Seattle Children's Hospital
Seattle, Washington 98195

More Details

NCT ID
NCT02744677
Status
Recruiting
Sponsor
Edwards Lifesciences

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.