NCT07140562

Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation

Prospective, Multi-Center, Single-Arm Study: Safety and Technical Feasibility of the Tangent Tricuspid Annular Therapy System for Transcatheter Valve Repair in Patients With Severe, Symptomatic Functional Tricuspid Regurgitation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Tangent Cardiovascular Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the safety and technical success of the Tangent Tricuspid Annular Therapy System in patients with severe, symptomatic functional tricuspid regurgitation.

Conditions

• Tricuspid Regurgitation Functional
• Tricuspid Regurgitation (TR)
• Tricuspid Regurgitation

Interventions

Type	Name	Description
DEVICE	Tricuspid Annular Therapy System	A transcatheter device designed for tricuspid valve repair.

Timeline

• Start date: 2025-07-15
• Primary completion: 2026-01-01
• Completion: 2026-12-01
• First posted: 2025-08-24
• Last updated: 2025-08-24

Locations

1 site across 1 country: Paraguay