๐๏ธ Verified NIH Record โข Updated 2025-11-18
Trisol System EFS Study (NCT04905017)
Early Feasibility Study of the Trisol System
๐ข Recruiting Observational / Diagnostic โ๏ธ Medical Device Protocol Sponsor: Trisol Medical
๐ฉบ 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
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ 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
๐ 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.
๐ฐ 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.
More studies in Tricuspid Regurgitation
- TRILUMINATE Pivotal Trial โ Birmingham, Alabama
- TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I) โ Phoenix, Arizona
- TTVR Early Feasibility Study โ Birmingham, Alabama
- Clinical Study of Edwards Cardioband FIT Valve Repair System โ Chicago, Illinois
- Laplace Early Feasibility Study - Canada โ Ottawa, Ontario
- Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System โ Tucson, Arizona
Explore by condition: All Tricuspid Regurgitation clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.