CorMatrix Cor TRICUSPID ECM Valve Replacement Study

Status Recruiting

Clinical Trial Summary

The Pivotal Study of the Cor TRICUSPID ECM Valve (or Cor PEDIATRIC Tricuspid ECM Valve). This study follows the EFS and is now to determine the safety and efficacy of the Cormatrix Cor TRICUSPID Valve for any patients requiring surgical replacement of the tricuspid valve.

Clinical Trial Description

CorMatrix Cardiovascular, Inc. has developed a device for heart valve replacement, the CorMatrix® Cor ECM® Tricuspid Valve, which can be implanted to replace dysfunctional tricuspid heart valves. This Pivotal Study is being performed to verify the ability to successfully implant the Tricuspid Valve, the clinical safety of the device, and whether the device performs its intended use. The study is a multi-center, prospective, single-arm, Pivotal Study of subjects receiving the Cor TRICUSPID ECM Valve or Cor PEDIATRIC Tricuspid ECM Valve. The study will be conducted at up to 15 sites. Up to 60 subjects will undergo tricuspid valve replacement (TVR) with the CorMatrix ECM Valve for the surgical management of tricuspid valve disease. The cohort will include up to 60 adult and 18 pediatric patients. ;

Study Design

Related Conditions & MeSH terms

Tricuspid Valve Disease

Clinical Trial Details

NCT number	NCT02397668
Study type	Interventional
Source	CorMatrix Cardiovascular, Inc.
Contact	Robert G Matheny, MD
Phone	404-276-7777
Email	rmatheny@cormatrix.com
Status	Recruiting
Phase	N/A
Start date	August 1, 2022
Completion date	December 15, 2024

View Details

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