NCT06212193

Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)

Early Feasibility Study (EFS) to Assess the Safety and Performance of the Innoventric Trillium™ Stent Graft in the Treatment of Severe or Greater Tricuspid Regurgitation (TR)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Innoventric LTD · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Early Feasibility Study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft in the treatment of severe or greater tricuspid regurgitation (TR).

Detailed description

Prospective, single arm, multi-center, Early Feasibility Study (EFS) to assess the safety and performance of the Innoventric Trillium™ Stent Graft in the treatment of severe or greater tricuspid regurgitation (TR). Up to fifteen (15) patients at up to 10 US investigational sites and 3 German investigational sites will be enrolled. All enrolled study patients will be assessed at baseline, during the procedure, at discharge, and after 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years following the index procedure.

Conditions

• Tricuspid Regurgitation
• Tricuspid Regurgitation Functional

Interventions

Type	Name	Description
DEVICE	Trillium™	Trillium™ Stent Graft for Cross-Caval Tricuspid Valve Replacement

Timeline

• Start date: 2024-08-05
• Primary completion: 2025-08-01
• Completion: 2030-08-01
• First posted: 2024-01-18
• Last updated: 2025-03-07

Locations

12 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated device study