🏛️ Verified NIH Record • Updated 2025-07-09
J-Valve TF Early Feasibility Study (NCT06034028)
🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
🩺 Plain-English Summary (8th-Grade Level)
The main objective of this study is to assess the preliminary safety and effectiveness of the J-Valve TF System in patients with symptomatic severe native aortic regurgitation who are judged by a multi-disciplinary heart team to be eligible for the device and to be at high risk for open surgical aortic valve replacement.
Who can join: Review the eligibility criteria below.
Location: HonorHealth — Scottsdale, Arizona
🧪 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 (9 Sites)
- HonorHealth — Scottsdale, Arizona
- MedStar Washington Hospital Center — Washington D.C., District of Columbia
- Advocate Christ Medical Center — Oak Lawn, Illinois
- Cardiovascular Institute of the South — Houma, Louisiana
- University at Buffalo — Buffalo, New York
- Montefiore Medical Center — The Bronx, New York
- The Christ Hospital — Cincinnati, Ohio
- Houston Methodist Hospital — Houston, Texas
- Swedish Medical Center Cherry Hill — Seattle, Washington
💰 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.