Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US) (NCT05848284)
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this clinical study is to evaluate the safety and clinical efficacy of the VDyne System in the treatment of symptomatic severe tricuspid regurgitation (TR).
Who can join: Review the eligibility criteria below.
Location: Cedars-Sinai Medical Center — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (11 Sites)
- Cedars-Sinai Medical Center — Los Angeles, California
- Henry Ford Hospital — Detriot, Michigan
- Minneapolis Heart Institute Foundation — Minneapolis, Minnesota
- Mayo Clinic - Rochester — Rochester, Minnesota
- Columbia University Medical Center/NYPH — New York, New York
- Montefiore Medical Center — The Bronx, New York
- The Christ Hospital — Cincinnati, Ohio
- Oregon Health and Science Unversity — Portland, Oregon
- Medical University of South Carolina — Charleston, South Carolina
- Ascension St. Thomas — Nashville, Tennessee
- Québec-Université Laval (IUCPQ-ULaval) — Québec, Quebec
📞 Contact the Study Coordinator
Phone: (763) 777-5969
Email: vpodichetty@vdyne.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.
More studies in Tricuspid Regurgitation
- TRILUMINATE Pivotal Trial — Birmingham, Alabama
- TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I) — Phoenix, Arizona
- TTVR Early Feasibility Study — Birmingham, Alabama
- Clinical Study of Edwards Cardioband FIT Valve Repair System — Chicago, Illinois
- Laplace Early Feasibility Study - Canada — Ottawa, Ontario
- Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System — Tucson, Arizona
Explore by condition: All Tricuspid Regurgitation clinical trials
💡 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.