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

Description

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

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Study Overview

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Study Details

Study overview

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.

COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV

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

Condition
Complex Congenital Heart Defect
Intervention / Treatment

-

Contacts and Locations

Little Rock

Arkansas Children's Hospital, Little Rock, Arkansas, United States, 72202

Los Angeles

University of California, Los Angeles, Los Angeles, California, United States, 90095

San Francisco

University of California,, San Francisco (UCSF), San Francisco, California, United States, 94143

Aurora

Childrens Hospital of Colorado, Aurora, Colorado, United States, 80045

Atlanta

Emory University/Children's Healthcare of Atlanta, Atlanta, Georgia, United States, 30322

Lexington

University of Kentucky, Lexington, Kentucky, United States, 40536

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115

Rochester

Mayo Clinic Rochester, Rochester, Minnesota, United States, 55905

Saint Louis

St. Louis Children's Hospital, Saint Louis, Missouri, United States, 63110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Edwards Lifesciences,

D. Scott Lim, MD, PRINCIPAL_INVESTIGATOR, University of Virginia Medical Center

Vasilis Babaliaros, MD, PRINCIPAL_INVESTIGATOR, Emory University Hospitals

Study Record Dates

2031-06