🏛️ Verified NIH Record • Updated 2026-07-30
A Prospective, Randomized Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation. (NCT06458907)
🟡 Not Yet Recruiting Observational / Diagnostic 💊 Investigational Drug / Biologic Sponsor: P+F Products + Features USA Inc.
🩺 Plain-English Summary (8th-Grade Level)
Pivotal trial to evaluate the safety and effectiveness of the P\&F TricValve® Transcatheter Bicaval Valve System.
Who can join: Review the eligibility criteria below.
Location: University of Alabama — Birmingham, Alabama
Age range: 18 Years to 85 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 (34 Sites)
Showing the first 25 of 34 sites.
- University of Alabama — Birmingham, Alabama
- St. Joseph's Hospital and Medical Center — Phoenix, Arizona
- UC Davis Health — Sacramento, California
- Scripps Memorial Hospital La Jolla — San Diego, California
- UCSF — San Francisco, California
- Kaiser Permanente — San Jose, California
- MedStar Washington Hospital Center (MWHC) — Washington D.C., District of Columbia
- Delray Medical Center — Delray Beach, Florida
- HCA Florida Largo Hospital — Largo, Florida
- Tampa General Hospital — Tampa, Florida
- Endeavor Health — Glenview, Illinois
- Ascension Medical Group St. Vincent The Heart Center of Indiana — Indianapolis, Indiana
- University of Kansas Medical Center — Kansas City, Kansas
- Cardiovascular Institute of the South — Houma, Louisiana
- Massachusetts General Hospital — Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- Lahey Hospital & Medical Center — Burlington, Massachusetts
- Minneapolis Heart Institute Foundation — Minneapolis, Minnesota
- Saint Luke's Mid America Heart Institute — Kansas City, Missouri
- Washington University of St Louis — St Louis, Missouri
- Hackensack University Medical Center — Hackensack, New Jersey
- Northwell Hospital — Manhasset, New York
- Montefiore Medical Center — The Bronx, New York
- Cleveland Clinic — Cleveland, Ohio
- Riverside Methodist Hospital — Columbus, Ohio
📞 Contact the Study Coordinator
Phone: (408) 839-3809
Email: tolender@productsandfeatures.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 Valve Disease
- CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study — Indianapolis, Indiana
- CorMatrix Cor TRICUSPID ECM Valve Replacement Study — Mobile, Alabama
Explore by condition: All Tricuspid Valve Disease 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.