๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-11-18

Trisol System EFS Study (NCT04905017)

Early Feasibility Study of the Trisol System

๐ŸŸข Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Trisol Medical

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The objective of this early feasibility study is to gain early clinical insight into Trisol system safety and performance to treat patients with moderate or greater tricuspid regurgitation (TR).

Who can join: Review the eligibility criteria below.

Location: Cedars-Sinai Medical Center โ€” Los Angeles, California

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (7 Sites)

  • Cedars-Sinai Medical Center โ€” Los Angeles, California
  • Piedmont Heart Institute โ€” Atlanta, Georgia
  • Columbia University Medical Center/NYPH โ€” New York, New York
  • Cleveland Clinic โ€” Cleveland, Ohio
  • Main Line Health / Lankenau Institute for Medical Research โ€” Wynnewood, Pennsylvania
  • Vanderbilt University Medical Center โ€” Nashville, Tennessee
  • University of Virginia Cardiology โ€” Charlottesville, Virginia

๐Ÿ“ž Contact the Study Coordinator

Phone: +972 528998866

Email: rond@trisol-medical.com

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

๐Ÿ’ฐ 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 ยง 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.

๐Ÿ’ก 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.
๐Ÿ›๏ธ View Official NIH Record โ†—