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Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement — FOLDAX  

Mitral Valve Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04717570
Study type Interventional
Source Foldax, Inc
Contact
Status Active, not recruiting
Phase N/A
Start date February 1, 2021
Completion date December 2025
View Details
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