NCT05913908

EFS of the DUO System for Tricuspid Regurgitation

Early Feasibility Study of the DUO Transcatheter Tricuspid Coaptation Valve System in Patients With Tricuspid Regurgitation

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

Summary

The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).

Detailed description

Multi-center, prospective, non-randomized, investigational, and pre-market. Data collected in this clinical study will include safety and function of the investigational system as well as up to 5 year clinical outcomes.

Conditions

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency
• Tricuspid Valve Disease
• Heart Valve Diseases

Interventions

Type	Name	Description
DEVICE	DUO Transcatheter Tricuspid Coaptation Valve System	Reduction of tricuspid regurgitation through a transcatheter approach

Timeline

• Start date: 2024-08-13
• Primary completion: 2025-12-01
• Completion: 2029-10-01
• First posted: 2023-06-22
• Last updated: 2025-11-10

Locations

16 sites across 2 countries: United States, Poland

Regulatory

• FDA-regulated device study