RECRUITING

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

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Conditions

Complex Congenital Heart DefectDysfunctional RVOT ConduitPulmonary Valve InsufficiencyPulmonary Valve DegenerationTetralogy of FallotAortic Valve Defect/Disease Resulting in Ross ProcedurePulmonary AtresiaPulmonary StenosisTruncus ArteriosusTransposition of the Great ArteriesTranscatheter pulmonary valve implantationTranscatheter pulmonary valve replacementTPVTPVRTPVI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2016-07-05
Study Completion:2031-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02744677

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.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Weight ≥ 20 kg (44 lbs.)
  2. 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. 3. Subject presents with at least moderate PR and/or mean RVOT gradient ≥ 35 mmHg.
  4. 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. 1. Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 2 weeks after discontinuation of antibiotics)
  2. 2. History of or active endocarditis (active treatment with antibiotics) within the past 180 days
  3. 3. Leukopenia, anemia, thrombocytopenia or any known blood clotting disorder
  4. 4. Inappropriate anatomy for femoral introduction and delivery of the study valve
  5. 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. 6. Angiographic evidence of coronary artery compression that would result from transcatheter pulmonic valve implantation (TPVI)
  7. 7. Interventional/surgical procedures within 30 days prior to the TPVI procedure.
  8. 8. Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TPVI procedure.
  9. 9. History of or current intravenous drug use
  10. 10. Major or progressive non-cardiac disease resulting in a life expectancy of less than one year
  11. 11. Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications
  12. 12. Known hypersensitivity to cobalt-chromium, nickel or contrast media that cannot be adequately premedicated
  13. 13. Participating in another investigational drug or device study that has not reached its primary endpoint.
  14. 14. Female who is lactating or pregnant

Contacts and Locations

Study Contact

Edwards THV Clinical Affairs
CONTACT
(949) 250-2500
THV_CT.gov@Edwards.com

Principal Investigator

D. Scott Lim, MD
PRINCIPAL_INVESTIGATOR
University of Virginia Medical Center
Vasilis Babaliaros, MD
PRINCIPAL_INVESTIGATOR
Emory University Hospitals

Study Locations (Sites)

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
Saint Louis, Missouri, 63110
United States
Washington University Barnes- Jewish Medical/ St. Louis Children's Hospital
Saint 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
LeBonheur Children's Hopsital
Memphis, Tennessee, 38103
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

Collaborators and Investigators

Sponsor: Edwards Lifesciences

  • D. Scott Lim, MD, PRINCIPAL_INVESTIGATOR, University of Virginia Medical Center
  • Vasilis Babaliaros, MD, PRINCIPAL_INVESTIGATOR, Emory University Hospitals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-07-05
Study Completion Date2031-06

Study Record Updates

Study Start Date2016-07-05
Study Completion Date2031-06

Terms related to this study

Keywords Provided by Researchers

  • Tetralogy of Fallot
  • Aortic Valve Defect/Disease Resulting in Ross Procedure
  • Pulmonary Atresia
  • Pulmonary Stenosis
  • Truncus Arteriosus
  • Transposition of the Great Arteries
  • Transcatheter pulmonary valve implantation
  • Transcatheter pulmonary valve replacement
  • TPV
  • TPVR
  • TPVI

Additional Relevant MeSH Terms

  • Complex Congenital Heart Defect
  • Dysfunctional RVOT Conduit
  • Pulmonary Valve Insufficiency
  • Pulmonary Valve Degeneration