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

Purpose

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.

Conditions

  • Complex Congenital Heart Defect
  • Dysfunctional RVOT Conduit
  • Pulmonary Valve Insufficiency
  • Pulmonary Valve Degeneration

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 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

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/SAPIEN 3 Ultra RESILIA THV
    SAPIEN 3/SAPIEN 3 Ultra RESILIA THV in the pulmonic position
Experimental
TPVR- S3UR Registry
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 Ultra RESILIA THV
    SAPIEN 3 Ultra RESILIA THV in the pulmonic position

Recruiting Locations

Arkansas Children's Hospital
Little Rock, Arkansas 72202

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

Boston Children's Hospital
Boston, Massachusetts 02115

St. Louis Children's Hospital
Saint Louis, Missouri 63110

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

Cincinnati Children's Hospital
Cincinnati, Ohio 45229

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

LeBonheur Children's Hopsital
Memphis, Tennessee 38103

Children's Health System of Texas / UT Southwestern Medical Center
Dallas, Texas 75235

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