Harmony TPV Post-Approval Study (Harmony PAS2)
Status: Active_not_recruiting
Location: See all (20) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• Patient eligible to receive the Harmony TPV, meeting the indications for use criteria per current geography-specific device labeling at time of study enrollment
• Patient (or patient's legally authorized representative) is willing to consent to participate in the study
Locations
United States
Alabama
University of Alabama at Birmingham Hospital
Birmingham
California
Cedars Sinai Medical Center
Los Angeles
Colorado
Children's Hospital Colorado
Aurora
Florida
St. Joseph Children's Hospital
Tampa
Illinois
Advocate Christ Medical Center
Oak Lawn
Massachusetts
Boston Children's Hospital
Boston
Michigan
University of Michigan Health System
Ann Arbor
Missouri
Saint Louis Children's Hospital
St Louis
North Carolina
Atrium Health Levine Children's Hospital
Charlotte
Duke University Medical Center
Durham
Nebraska
Children's Hospital & Medical Center
Omaha
New York
Children's Hospital New York - Presbyterian
New York
The Mount Sinai Hospital
New York
Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati
Cleveland Clinic
Cleveland
Pennsylvania
UPMC Children's Hospital of Pittsburgh
Pittsburgh
South Carolina
Medical University of South Carolina
Charleston
Texas
Medical City Children's Hospital
Dallas
Virginia
University of Virginia
Charlottesville
Other Locations
Canada
University of Alberta Hospital
Edmonton
Time Frame
Start Date: 2021-10-25
Completion Date: 2035-03
Participants
Target number of participants: 150
Treatments
Other: Harmony TPV System
Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery System
Related Therapeutic Areas
Sponsors
Leads: Medtronic Cardiovascular