ποΈ Verified NIH Record β’ Updated 2026-05-29
Harmony TPV Post-Approval Study (NCT05077774)
Harmony TPV Post-Approval Study (Harmony PAS2)
π΅ Active, Not Recruiting Observational / Diagnostic βοΈ Medical Device Protocol Sponsor: Medtronic Cardiovascular
π©Ί Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham Hospital β Birmingham, Alabama
π§ͺ Interventions in This Study
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria β
π All Participating Trial Locations (20 Sites)
- University of Alabama at Birmingham Hospital β Birmingham, Alabama
- Cedars Sinai Medical Center β Los Angeles, California
- Children's Hospital Colorado β Aurora, Colorado
- St. Joseph Children's Hospital β Tampa, Florida
- Advocate Christ Medical Center β Oak Lawn, Illinois
- Boston Children's Hospital β Boston, Massachusetts
- University of Michigan Health System β Ann Arbor, Michigan
- Saint Louis Children's Hospital β St Louis, Missouri
- Children's Hospital & Medical Center β Omaha, Nebraska
- The Mount Sinai Hospital β New York, New York
- Children's Hospital New York - Presbyterian β New York, New York
- Atrium Health Levine Children's Hospital β Charlotte, North Carolina
- Duke University Medical Center β Durham, North Carolina
- Cincinnati Children's Hospital Medical Center β Cincinnati, Ohio
- Cleveland Clinic β Cleveland, Ohio
- UPMC Children's Hospital of Pittsburgh β Pittsburgh, Pennsylvania
- Medical University of South Carolina β Charleston, South Carolina
- Medical City Children's Hospital β Dallas, Texas
- University of Virginia β Charlottesville, Virginia
- University of Alberta Hospital β Edmonton, Alberta
π° Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Congenital Heart Disease
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- The Medtronic Harmonyβ’ Transcatheter Pulmonary Valve Clinical Study β Los Angeles, California
- Autus Valve Pivotal Study β Los Angeles, California
- Peer Coaching Intervention in Young Adults With Congenital Heart Disease β Durham, North Carolina
- SGLT2 Inhibition With Empagliflozin in Fontan Circulatory Failure β Toronto, Ontario
Explore by condition: All Congenital Heart Disease clinical trials
π‘ How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.