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Clinical Trials in the USA / NCT02744677
Recruiting Not applicable

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

NCT02744677 · tracked via the Priya Life Science USA tracker
Sponsor
Edwards Lifesciences
Phase
Not applicable
Started
2016-07-05
Last updated
2026-07-23

Condition(s) studied

Complex Congenital Heart DefectDysfunctional RVOT ConduitPulmonary Valve InsufficiencyPulmonary Valve Degeneration

Investigational drug(s) / intervention(s)

SAPIEN 3/SAPIEN 3 Ultra RESILIA THVSAPIEN 3 THVSAPIEN 3 Ultra RESILIA THV

SAPIEN 3/SAPIEN 3 Ultra RESILIA THV: SAPIEN 3/SAPIEN 3 Ultra RESILIA THV in the pulmonic position

SAPIEN 3 THV: SAPIEN 3 THV in the pulmonic position

SAPIEN 3 Ultra RESILIA THV: SAPIEN 3 Ultra RESILIA THV in the pulmonic position

Study 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

Sex
ALL
Min age
Max age
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

Primary outcome measure(s)

Trial sites (27)

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University of Kentucky Lexington Kentucky Withdrawn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

More Edwards Lifesciences trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02744677 on ClinicalTrials.gov ↗ ← All trials in the USA