COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
NCT ID: NCT02744677
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
108 participants
INTERVENTIONAL
2016-07-05
2031-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TPVR - Main Cohort
Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).
SAPIEN 3 THV
SAPIEN 3 THV in the pulmonic position
TPVR - THV Registry
Subjects with a previously implanted transcatheter valve in the pulmonic position will undergo TPVR.
SAPIEN 3/SAPIEN 3 Ultra RESILIA THV
SAPIEN 3/SAPIEN 3 Ultra RESILIA THV in the pulmonic position
TPVR- S3UR Registry
Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).
SAPIEN 3 Ultra RESILIA THV
SAPIEN 3 Ultra RESILIA THV in the pulmonic position
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Edwards Lifesciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
D. Scott Lim, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia Medical Center
Vasilis Babaliaros, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University Hospitals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Arkansas Children's Hospital
Little Rock, Arkansas, United States
University of California, Los Angeles
Los Angeles, California, United States
University of California,, San Francisco (UCSF)
San Francisco, California, United States
Childrens Hospital of Colorado
Aurora, Colorado, United States
Emory University/Children's Healthcare of Atlanta
Atlanta, Georgia, United States
University of Kentucky
Lexington, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Washington University Barnes- Jewish Medical/ St. Louis Children's Hospital
St Louis, Missouri, United States
Columbia University Medical Center/NYPH
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
The Lindner Research Center at Christ Hospital
Cincinnati, Ohio, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Penn Presbyterian Medical Center, University of Pennsylvania/ Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
LeBonheur Children's Hopsital
Memphis, Tennessee, United States
Medical City Dallas
Dallas, Texas, United States
Children's Health System of Texas / UT Southwestern Medical Center
Dallas, Texas, United States
Methodist San Antonio
San Antonio, Texas, United States
Intermountain Heart Institute (IMC)
Murray, Utah, United States
University of Virginia (UVA)
Charlottesville, Virginia, United States
University of Washington/Seattle Children's Hospital
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Lim DS, Kim D, Aboulhosn J, Levi D, Fleming G, Hainstock M, Sommer R, Torres AJ, Zhao Y, Shirali G, Babaliaros V. Congenital Pulmonic Valve Dysfunction Treated With SAPIEN 3 Transcatheter Heart Valve (from the COMPASSION S3 Trial). Am J Cardiol. 2023 Mar 1;190:102-109. doi: 10.1016/j.amjcard.2022.12.010. Epub 2023 Jan 4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-01
Identifier Type: -
Identifier Source: org_study_id