TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I) (NCT06137807)
A Prospective, Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation - TRICAV-I Trial
🩺 Plain-English Summary (8th-Grade Level)
The TricValve® Transcatheter Bicaval Valve System is a bicaval transcatheter tricuspid valve replacement system, which includes the TricValve® Transcatheter Bicaval Valve for superior vena cava (SVC) and the TricValve® Transcatheter Bicaval Valve for inferior vena cava (IVC). The TricValve® Transcatheter Bicaval Valves are pre-mounted into the TricValve® Delivery System which is used for percutaneous access and delivery of the TricValve® Transcatheter Bicaval Valve in the vena cava. The system is a single use, sterile device compatible with all the valve sizes. The prostheses are implanted percutaneously into the inferior and superior vena cava without disturbing the native tricuspid valve. The device is made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system.
Who can join: Review the eligibility criteria below.
Location: St. Joseph's Hospital and Medical Center — Phoenix, Arizona
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 (36 Sites)
Showing the first 25 of 36 sites.
- St. Joseph's Hospital and Medical Center — Phoenix, Arizona
- Tucson Medical Center — Tucson, Arizona
- Scripps Memorial Hospital La Jolla — San Diego, California
- UCSF — San Francisco, California
- Delray Medical Center — Delray Beach, Florida
- Largo Medical Center — Largo, Florida
- Tampa General Hospital — Tampa, Florida
- Endeavor Health, Glenbrook Hospital — Glenview, Illinois
- Chicago Advocate Christ — Palos Park, Illinois
- Ascension Medical Group St. Vincent The Heart Center of Indiana — Indianapolis, Indiana
- 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 St Louis — St Louis, Missouri
- Hackensack University Medical Center — Hackensack, New Jersey
- North Shore University Hospital — Manhasset, New York
- Montefiore Medical Center — The Bronx, New York
- Duke Cardiology Clinic — Durham, North Carolina
- Cleveland Clinic — Cleveland, Ohio
- Riverside Methodist Hospital — Columbus, Ohio
- Oregon Health Services — Portland, Oregon
- UPMC Pinnacle — Harrisburg, Pennsylvania
💰 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
- 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.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.