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CorMatrix Cor TRICUSPID ECM Valve Replacement Study

NCT02397668 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2025-09-02

No results posted yet for this study

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.

Conditions

  • Tricuspid Valve Disease

Interventions

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.

Sponsors & Collaborators

  • CorMatrix Cardiovascular, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert G Matheny, MD · CorMatrix Cardiovascular, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2025-12-15
Completion
2026-12-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02397668 on ClinicalTrials.gov