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

Recruiting now · Not applicable

Conditions studied: Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration

In brief

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.

Key facts

Study ID

NCT02744677

Run by

Edwards Lifesciences

People needed

108

Starts

2016-07-05

Expected to finish

2031-06-01

Last updated by the study team

2026-07-23

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Weight ≥ 20 kg (44 lbs.)
• 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
• Subject presents with at least moderate PR and/or mean RVOT gradient ≥ 35 mmHg.
• 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 may not qualify if…

• Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 2 weeks after discontinuation of antibiotics)
• History of or active endocarditis (active treatment with antibiotics) within the past 180 days
• Leukopenia, anemia, thrombocytopenia or any known blood clotting disorder
• Inappropriate anatomy for femoral introduction and delivery of the study valve
• 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
• Angiographic evidence of coronary artery compression that would result from transcatheter pulmonic valve implantation (TPVI)
• Interventional/surgical procedures within 30 days prior to the TPVI procedure.
• Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TPVI procedure.
• History of or current intravenous drug use
• Major or progressive non-cardiac disease resulting in a life expectancy of less than one year
• Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications
• Known hypersensitivity to cobalt-chromium, nickel or contrast media that cannot be adequately premedicated
• Participating in another investigational drug or device study that has not reached its primary endpoint.
• Female who is lactating or pregnant

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• Arkansas Children's Hospital — Little Rock, Arkansas, United States (enrolling)
• Vanderbilt University — Nashville, Tennessee, United States (enrolling)
• Medical City Dallas — Dallas, Texas, United States (enrolling)
• Children's Health System of Texas / UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• Methodist San Antonio — San Antonio, Texas, United States (enrolling)
• Intermountain Heart Institute (IMC) — Murray, Utah, United States (enrolling)
• University of Virginia (UVA) — Charlottesville, Virginia, United States (enrolling)
• University of California,, San Francisco (UCSF) — San Francisco, California, United States (enrolling)
• Childrens Hospital of Colorado — Aurora, Colorado, United States (enrolling)
• Emory University/Children's Healthcare of Atlanta — Atlanta, Georgia, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
• Mayo Clinic Rochester — Rochester, Minnesota, United States (enrolling)
• St. Louis Children's Hospital — St Louis, Missouri, United States (enrolling)
• Columbia University Medical Center/NYPH — New York, New York, United States (enrolling)
• Duke University Medical Center — Durham, North Carolina, United States (enrolling)
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States (enrolling)
• Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
• UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)
• LeBonheur Children's Hopsital — Memphis, Tennessee, United States (enrolling)
• University of California, Los Angeles — Los Angeles, California, United States
• Penn Presbyterian Medical Center, University of Pennsylvania/ Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• University of Washington/Seattle Children's Hospital — Seattle, Washington, United States
• The Lindner Research Center at Christ Hospital — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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