NCT02397668

CorMatrix Cor TRICUSPID ECM Valve Replacement Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Corvivo Cardiovascular, Inc. · Industry
• Sex: All
• Age: 1 Year – 85 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Tricuspid Valve Disease

Interventions

Type	Name	Description
DEVICE	CorMatrix Cor TRICUSPID ECM Valve	CorMatrix Cor TRICUSPID ECM Valve to replace a diseased tricuspid valve, including tricuspid valve disease secondary to congenital heart disease.

Timeline

• Start date: 2022-08-01
• Primary completion: 2025-12-15
• Completion: 2026-12-15
• First posted: 2015-03-25
• Last updated: 2025-09-02

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study