NCT06038838

Feasibility Study of the Tioga TMVR System

Evaluation of Safety and Feasibility of the Tioga TMVR System for Treatment of Mitral Regurgitation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tioga Cardiovascular, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is aimed to assess the safety and feasibility of the Tioga TMVR System in treating patients with symptomatic MR (MR\>=3+)

Detailed description

The Tioga TMVR Feasibility Study is a prospective, single-arm, multi-center study with a planned enrollment of up to 30 patients. The Tioga TMVR System is designed to percutaneously replace a patient's diseased native mitral valve with a bioprosthetic valve. The investigational device is intended for transseptal replacement of the mitral valve in patients with symptomatic MR (MR\>=3+).

Conditions

• Mitral Regurgitation

Interventions

Type	Name	Description
DEVICE	Tioga TMVR System	A bioprosthetic mitral valve, as part of the Tioga TMVR System, is implanted percutaneously in a patient with MR via transfemoral-transseptal access.

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-07-01
• Completion: 2028-07-01
• First posted: 2023-09-15
• Last updated: 2025-11-12

Locations

5 sites across 4 countries: Brazil, Georgia, Lithuania, Paraguay

Regulatory

• FDA-regulated device study