RECRUITING
I'm interested ...!!
ALTERRA Post-Approval Study
This study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting
Conditions:
🦠 Pulmonary Valve Insufficiency 🦠 Complex Congenital Heart Defect 🦠 Tetralogy of Fallot 🦠 Pulmonary Regurgitation 🦠 RVOT Anomaly
🗓️ Study Start (Actual) 12 May 2022
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) December 2034
👥 Enrollment (Estimated) 150
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Birmingham, Alabama, United States
📍 Little Rock, Arkansas, United States
📍 Los Angeles, California, United States
📍 San Diego, California, United States
📍 Stanford, California, United States
📍 Aurora, Colorado, United States
📍 Oak Lawn, Illinois, United States
📍 Boston, Massachusetts, United States
📍 Rochester, Minnesota, United States
📍 Saint Louis, Missouri, 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
📍 Pittsburgh, Pennsylvania, United States
📍 Dallas, Texas, United States
📍 Houston, Texas, United States
📍 Salt Lake City, Utah, United States
📍 Charlottesville, Virginia, United States
📍 Seattle, Washington, United States
📍 Petah Tikva, Israel
More locations available...

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Native or surgically-repaired RVOT with severe PR
    • 2. Clinically indicated for pulmonary valve replacement
    • 3. Planned for treatment with the Alterra prestent and SAPIEN 3 THV

    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 12 May 2022
  • First Submitted that Met QC Criteria 12 May 2022
  • First Posted 18 May 2022

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 ...!!