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Harmony TPV Post-Approval Study
Sponsor: Medtronic Cardiovascular
Summary
The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.
Official title: Harmony TPV Post-Approval Study (Harmony PAS2)
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2021-10-25
Completion Date
2035-03
Last Updated
2026-01-08
Healthy Volunteers
No
Interventions
Harmony TPV System
Harmony Transcatheter Pulmonary Valve (sizes 22 mm and 25 mm) and Harmony Delivery Catheter System (DCS)
Locations (20)
University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
St. Joseph Children's Hospital
Tampa, Florida, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Saint Louis Children's Hospital
St Louis, Missouri, United States
Children's Hospital & Medical Center
Omaha, Nebraska, United States
The Mount Sinai Hospital
New York, New York, United States
Children's Hospital New York - Presbyterian
New York, New York, United States
Atrium Health Levine Children's Hospital
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Medical City Children's Hospital
Dallas, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
University of Alberta Hospital
Edmonton, Alberta, Canada