🏛️ 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: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (35 items).

Location: HonorHealth — Scottsdale, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Patients that are at prohibitive surgical risk (predicted risk for mortality or major morbidity at 30 days \>50% with SAVR);
  • Mixed aortic valve disease, defined as coexistence of \> moderate aortic valve stenosis with severe AR;
  • Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, ticlopidine, clopidogrel, Nitinol (Nickel, Titanium, Aluminum) or sensitivity to contrast media, which cannot be adequately premedicated;
  • Blood dyscrasias as defined: leukopenia (WBC \<1000 mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy;
  • Active infection, including infective endocarditis;
  • Liver failure (Child-C);
  • Reduced left ventricular function with left ventricular ejection fraction (LVEF) \<25% as measured by resting echocardiogram;
  • Uncontrolled atrial fibrillation (e.g., resting heart rate \>120 bpm);
  • Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements;
  • Renal insufficiency (eGFR \<25) and/or end stage renal disease requiring chronic dialysis;
  • Pulmonary Hypertension (systolic pressure ≥2/3 of systemic);

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 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.
🏛️ View Official NIH Record ↗