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COMPASSION S3 Post-Approval Study
This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical 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 🦠 Pulmonary Valve; Obstruction
🗓️ Study Start (Actual) 13 April 2021
🗓️ Primary Completion (Estimated) August 2030
✅ Study Completion (Estimated) August 2030
👥 Enrollment (Estimated) 150
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Birmingham, Alabama, United States
📍 Los Angeles, California, United States
📍 Aurora, Colorado, United States
📍 Atlanta, Georgia, United States
📍 Oak Lawn, Illinois, United States
📍 Boston, Massachusetts, United States
📍 Minneapolis, Minnesota, United States
📍 Saint Louis, Missouri, United States
📍 Newark, New Jersey, United States
📍 New York, New York, United States
📍 New York, New York, United States
📍 Durham, North Carolina, United States
📍 Cincinnati, Ohio, United States
📍 Columbus, Ohio, United States
📍 Philadelphia, Pennsylvania, United States
📍 Pittsburgh, Pennsylvania, United States
📍 Austin, Texas, United States
📍 Dallas, Texas, United States
📍 Salt Lake City, Utah, United States
📍 Charlottesville, Virginia, United States
More locations available...

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Dysfunctional RVOT conduit or previously implanted surgical valve
    • 2. RVOT/PV with ≥ moderate regurgitation and/or a mean RVOT/PV gradient of ≥ 35 mmHg

    Exclusion Criteria:

    • 1. Inability to tolerate an anticoagulation/antiplatelet regimen
    • 2. Active bacterial endocarditis or other active infections
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 23 April 2021
  • First Submitted that Met QC Criteria 23 April 2021
  • First Posted 27 April 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 12 March 2024
  • Last Update Posted 13 March 2024
  • Last Verified March 2024
I'm interested ...!!