🏛️ Verified NIH Record • Updated 2025-09-09
The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study (NCT02979587)
🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Medtronic Heart Valves
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of transcatheter implantation of the Medtronic Harmony TPV.
Who can join: Review the eligibility criteria below.
Location: Ronald Regan UCLA Medical Center — Los Angeles, California
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (12 Sites)
- Ronald Regan UCLA Medical Center — Los Angeles, California
- Stanford University Medical Center — Palo Alto, California
- Yale University — New Haven, Connecticut
- Mayo Clinic — Rochester, Minnesota
- Nationwide Children's Hospital — Columbus, Ohio
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- Texas Children's Hospital — Houston, Texas
- Primary Children's Hospital — Salt Lake City, Utah
- Seattle Children's Hospital — Seattle, Washington
- The Hospital for Sick Children (SickKids) — Toronto, Ontario
- Toronto General Hospital — Toronto, Ontario
- National Cerebral and Cardiovascular Center — Suita, Osaka
💰 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 § 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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Explore by condition: All Congenital Heart Disease clinical trials
💡 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.