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NCT02744677NARecruiting

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

Edwards Lifesciences

Start Date

7/5/2016

Completion Date

6/1/2031

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.

Eligibility Criteria

Age Range: No minimum to No maximum

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

Interventions

DEVICE

SAPIEN 3/SAPIEN 3 Ultra RESILIA THV

DEVICE

SAPIEN 3 THV

DEVICE

SAPIEN 3 Ultra RESILIA THV

Interested in This Trial?

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Conditions

Complex Congenital Heart DefectDysfunctional RVOT ConduitPulmonary Valve InsufficiencyPulmonary Valve Degeneration

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35233

United States

Arkansas Children's Hospital

Little Rock, Arkansas 72202

United States

University of California, Los Angeles

Los Angeles, California 90095

United States

University of California,, San Francisco (UCSF)

San Francisco, California 94143

United States

Childrens Hospital of Colorado

Aurora, Colorado 80045

United States

Emory University/Children's Healthcare of Atlanta

Atlanta, Georgia 30322

United States

University of Kentucky

Lexington, Kentucky 40536

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Boston Children's Hospital

Boston, Massachusetts 02115

United States

Mayo Clinic Rochester

Rochester, Minnesota 55905

United States

St. Louis Children's Hospital

St Louis, Missouri 63110

United States

Washington University Barnes- Jewish Medical/ St. Louis Children's Hospital

St Louis, Missouri 63110

United States

Columbia University Medical Center/NYPH

New York, New York 10032

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

The Lindner Research Center at Christ Hospital

Cincinnati, Ohio 45219

United States

Cincinnati Children's Hospital

Cincinnati, Ohio 45229

United States

Nationwide Children's Hospital

Columbus, Ohio 43205

United States

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

Philadelphia, Pennsylvania 19104

United States

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania 15224

United States

LeBonheur Children's Hopsital

Memphis, Tennessee 38103

United States

Vanderbilt University

Nashville, Tennessee 37232

United States

Medical City Dallas

Dallas, Texas 75230

United States

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

Dallas, Texas 75235

United States

Methodist San Antonio

San Antonio, Texas 78229

United States

Intermountain Heart Institute (IMC)

Murray, Utah 84107

United States

University of Virginia (UVA)

Charlottesville, Virginia 22908

United States

University of Washington/Seattle Children's Hospital

Seattle, Washington 98195

United States