AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingNAAges any - anyAllEdwards Lifesciences
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Weight โ‰ฅ 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 โ‰ฅ 16.5 mm and โ‰ค 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 โ‰ฅ 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
๐Ÿ’Š

What it tests

  • SAPIEN 3/SAPIEN 3 Ultra RESILIA THV
  • SAPIEN 3 THV
  • SAPIEN 3 Ultra RESILIA THV
๐Ÿ“

Where

27 sites
University of Alabama at Birmingham
Birmingham, United States
Arkansas Children's Hospital
Little Rock, United States
University of California, Los Angeles
Los Angeles, United States
University of California,, San Francisco (UCSF)
San Francisco, United States
Childrens Hospital of Colorado
Aurora, United States
Emory University/Children's Healthcare of Atlanta
Atlanta, United States
University of Kentucky
Lexington, United States
Massachusetts General Hospital
Boston, United States

โ€ฆand 19 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy