Clinical Investigation for the Foldax Tria Mitral Valve- India

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to conduct a clinical investigation of the Foldax Tria Mitral Valve to collect evidence on the device's safety and performance.

Clinical Trial Description

The Foldax Tria Mitral Heart Valve is indicated as a replacement for diseased, damaged, or malfunctioning native mitral heart valve via open heart surgery. The study is a single open are label non-randomized multi- center clinical trial. Up to 10 sites in the country of India will enroll up to 70 patients. The first two patients at each site, will be considered roll-in patients accounting for training. Up to 50 patients will be considered part of the treatment phase. These patients will follow the study schedule for 1 year after implantation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06191718
Study type	Interventional
Source	Foldax, Inc
Contact
Status	Active, not recruiting
Phase	N/A
Start date	March 1, 2023
Completion date	December 1, 2024

View Details

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