NCT04717570

Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement

Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement Investigational Device Exemption

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Foldax, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Mitral Valve to collect evidence on the device's safety and performance. The study is anticipated to confirm successful clinical safety and clinical effectiveness with significant improvements in clinical hemodynamic performance.

Detailed description

The Foldax Polymer Mitral Valve is indicated as a replacement for a diseased, damaged, or malfunctioning native mitral heart valve via open heart surgery. This is a first in human study conducted under US FDA's Early Feasibility Investigational Device Exemption and will enroll up to 15 patients. These patients will be followed up to 5 years after implantation.

Conditions

• Mitral Valve Disease
• Mitral Valve Stenosis
• Mitral Valve Failure

Interventions

Type	Name	Description
DEVICE	Foldax TRIA Mitral Valve	Mitral Valve Replacement

Timeline

• Start date: 2021-02-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2021-01-22
• Last updated: 2023-09-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study