🏛️ Verified NIH Record • Updated 2023-09-11
Early Feasibility Study for the Foldax Tria Aortic Heart Valve (NCT03851068)
🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Foldax, Inc
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Aortic Valve to collect evidence on the device's safety and performance. The study is anticipated to confirm successful clinical safety and clinical effectiveness with significant improvements in clinical hemodynamic performance.
Who can join: Review the eligibility criteria below.
Location: St. Vincent Hospital — Indianapolis, Indiana
Age range: 18 Years
🧪 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 (5 Sites)
- St. Vincent Hospital — Indianapolis, Indiana
- Ascension Via Christi St. Francis Hospital — Wichita, Kansas
- William Beaumont Hospital — Detroit, Michigan
- The Christ Hospital — Cincinnati, Ohio
- OhioHealth Riverside — Columbus, Ohio
💰 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 Aortic Valve 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.