🏛️ Verified NIH Record • Updated 2026-04-15

Early Feasibility Study of the NORM™ System in Heart Failure Patients (FUTURE-HFII) (NCT05763407)

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Foundry Innovation & Research 1, Limited (FIRE1)

🩺 Plain-English Summary (8th-Grade Level)

Early Feasibility Study of the NORM™ System in Heart Failure Patients

Who can join: Review the eligibility criteria below.

Location: University of Minnesota Medica Center — Minneapolis, Minnesota

Age range: 18 Years

🧪 Interventions in This Study

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

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (8 Sites)

  • University of Minnesota Medica Center — Minneapolis, Minnesota
  • Columbia University Irving Medical Center/ New York Presbyterian Hospital — New York, New York
  • Rochester General Hospital — Rochester, New York
  • Duke University Medical Center — Durham, North Carolina
  • Cleveland Clinic — Cleveland, Ohio
  • The Ohio State University Wexner Medical Center — Columbus, Ohio
  • Prisma Health — Greenville, South Carolina
  • Austin Heart Central at the Heart Hospital of Austin — Austin, Texas

💰 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.

Explore by condition: All Heart Failure clinical trials

💡 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.
🏛️ View Official NIH Record ↗