NCT06458907

TRICAV-II Pivotal: TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation.

A Prospective, Multicenter, Randomized, Clinical Trial of the TricValve Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation (TR).

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: P+F Products + Features USA Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The Investigational Device is the TricValve Transcatheter Bicaval Valve System (also referred to as the TricValve System). The bioprosthesis is available in two different diameters for each model (SVC and IVC) specifically designed to adapt to the anatomic features of the superior vena cava (SVC) and inferior vena cava (IVC). The SVC and IVC valves are single use, sterile devices provided in two sizes each, for a total of four valve sizes. The valves are designed for heterotopic caval implantation without perturbing the native tricuspid valve. The valves are made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system. The SVC and IVC valves are provided pre-mounted in two separate TricValve Delivery Systems, and are individually packaged into two separate boxes, provided sterile and ready to use. The two TricValve Delivery Systems deliver the two valves percutaneously into the SVC and IVC via femoral vein access using a transvenous approach.

Detailed description

This is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the TricValve System with Optimal Medical Therapy (OMT) compared to OMT alone in the treatment of patients with severe TR and caval reflux (CR). The TricValve System received Breakthrough Device Designation from the US FDA.

Conditions

• Tricuspid Regurgitation
• Tricuspid Valve Disease

Interventions

Type	Name	Description
DEVICE	TricValve® Transcatheter Bicaval Valve System	TricValve® Device (Device) Group subjects will undergo TricValve® implantation and will continue to be managed with optimal medical therapies.
DRUG	Optimal medical therapy	Optimal medical therapy

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-12-01
• Completion: 2030-01-01
• First posted: 2024-06-14
• Last updated: 2024-07-03

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated device study