🏛️ Verified NIH Record • Updated 2025-03-05

Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS) (NCT06212193)

Early Feasibility Study (EFS) to Assess the Safety and Performance of the Innoventric Trillium™ Stent Graft in the Treatment of Severe or Greater Tricuspid Regurgitation (TR)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Innoventric LTD

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

Early Feasibility Study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft in the treatment of severe or greater tricuspid regurgitation (TR).

Who can join: Review the eligibility criteria below.

Location: Cardiovascular Institute of Los Robles Health System — Thousand Oaks, California

Age range: 18 Years to 85 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 (12 Sites)

  • Cardiovascular Institute of Los Robles Health System — Thousand Oaks, California
  • Ascension St. John — Detroit, Michigan
  • Mayo Clinic Hospital (Rochester) — Rochester, Minnesota
  • Weill Cornell Medicine — New York, New York
  • Stony Brook Heart Institute — Stony Brook, New York
  • The Christ Hospital — Cincinnati, Ohio
  • Lankenau Heart Institute — Philadelphia, Pennsylvania
  • TriStar Centennial Medical Center — Nashville, Tennessee
  • University of Washington Medical Center — Seattle, Washington
  • University Medicine Mainz — Mainz, Rhineland-Palatinate
  • Helios Health Institute GmbH, Leipzig — Leipzig, Saxony
  • German Heart Center at Charité (DHZC) — Berlin, State of Berlin

📞 Contact the Study Coordinator

Phone: +972-52-8981783

Email: chen@innoventric.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 ↗