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 Sex
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 4119403, Arkansas 4099753 72202

University of California,, San Francisco (UCSF)
San Francisco 5391959, California 5332921 94143

Childrens Hospital of Colorado
Aurora 5412347, Colorado 5417618 80045

Emory University/Children's Healthcare of Atlanta
Atlanta 4180439, Georgia 4197000 30322

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114

Boston Children's Hospital
Boston 4930956, Massachusetts 6254926 02115

Mayo Clinic Rochester
Rochester 5043473, Minnesota 5037779 55905

St. Louis Children's Hospital
St Louis 4407066, Missouri 4398678 63110

Columbia University Medical Center/NYPH
New York 5128581, New York 5128638 10032

Duke University Medical Center
Durham 4464368, North Carolina 4482348 27710

Cincinnati Children's Hospital
Cincinnati 4508722, Ohio 5165418 45229

Nationwide Children's Hospital
Columbus 4509177, Ohio 5165418 43205

UPMC Children's Hospital of Pittsburgh
Pittsburgh 5206379, Pennsylvania 6254927 15224

LeBonheur Children's Hopsital
Memphis 4641239, Tennessee 4662168 38103

Medical City Dallas
Dallas 4684888, Texas 4736286 75230

Children's Health System of Texas / UT Southwestern Medical Center
Dallas 4684888, Texas 4736286 75235

Methodist San Antonio
San Antonio 4726206, Texas 4736286 78229

Intermountain Heart Institute (IMC)
Murray 5778755, Utah 5549030 84107

University of Virginia (UVA)
Charlottesville 4752031, Virginia 6254928 22908

More Details

NCT ID
NCT02744677
Status
Recruiting
Sponsor
Edwards Lifesciences

Study Contact

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