πŸ›οΈ Verified NIH Record β€’ Updated 2026-05-29

Harmony TPV Post-Approval Study (NCT05077774)

Harmony TPV Post-Approval Study (Harmony PAS2)

πŸ”΅ Active, Not Recruiting Observational / Diagnostic βš™οΈ Medical Device Protocol Sponsor: Medtronic Cardiovascular

🩺 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

πŸ§ͺ Interventions in This Study

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ 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

πŸ’° 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.

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πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—