Early Feasibility Study for the Foldax Tria Aortic Heart Valve

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Aortic 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 Aortic Valve is indicated as a replacement for a diseased, damaged, or malfunctioning native aortic 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 40 patients. These patients will be followed up to 5 years after implantation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03851068
Study type	Interventional
Source	Foldax, Inc
Contact
Status	Active, not recruiting
Phase	N/A
Start date	June 18, 2019
Completion date	December 2026

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