🏛️ Verified NIH Record • Updated 2026-05-28

EFS of the DUO System for Tricuspid Regurgitation (NCT05913908)

Early Feasibility Study of the DUO Transcatheter Tricuspid Coaptation Valve System in Patients With Tricuspid Regurgitation

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: CroiValve Limited

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

The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).

Who can join: Review the eligibility criteria below.

Location: Dignity Health St. Joseph's Hospital & Medical Center — Phoenix, Arizona

Age range: 18 Years

📋 "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 (15 Sites)

  • Dignity Health St. Joseph's Hospital & Medical Center — Phoenix, Arizona
  • Los Robles Hospital & Medical Center — Thousand Oaks, California
  • Piedmont Heart Institute — Atlanta, Georgia
  • Northwestern University — Chicago, Illinois
  • Ascension Via Christi Research — Wichita, Kansas
  • Allina Health Minneapolis Heart Institute Foundation — Minneapolis, Minnesota
  • Columbia University Medical Center/NYPH — New York, New York
  • OhioHealth Research Institute — Columbus, Ohio
  • UPMC Pinnacle Harrisburg — Harrisburg, Pennsylvania
  • San Antonio Methodist — San Antonio, Texas
  • Intermountain Health — Salt Lake City, Utah
  • University of Washington — Seattle, Washington
  • Uniwersytetem Medycznym im. Karola Marcinkowskiego w Poznaniu — Poznan, Poznan
  • Narodowym Instytutem Kardiologii Stefana Kardynała Wyszyńskiego - Państwowym Instytutem Badawczym — Warsaw, Warsaw
  • Medical University of Silesia — Katowice,

📞 Contact the Study Coordinator

Phone: (612) 229-9950

Email: Helen@CroiValve.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 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.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  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 ↗