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CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study

NCT05742906 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-09-02

No results posted yet for this study

Summary

The goal of this pivotal study is to demonstrate the safety and performance of the Cor TRICUSPID ECM (extracellular matrix) Valve (or Cor PEDIATRIC Tricuspid ECM Valve) for the surgical management of tricuspid valve disease and dysfunction in adult and pediatric patients. The main question(s) it aims to answer are:

* whether the device may be implanted successfully and safely, and
* whether the device effectively treats tricuspid valve disease and dysfunction through 12 months

Participants will undergo:

* preoperative evaluation
* tricuspid valve replacement with the Cor TRICUSPID ECM Valve
* postoperative evaluation, including at hospital discharge, 30 days, 6 months, and 12 months, and then annually thereafter through 5 years

Conditions

  • Tricuspid Valve Disease
  • Tricuspid Valve Insufficiency

Interventions

DEVICE

Tricuspid valve replacement with the Cor TRICUSPID ECM Valve

Tricuspid valve replacement with the Cor TRICUSPID ECM Valve for the surgical management of tricuspid valve disease or dysfunction.

Sponsors & Collaborators

  • Yale University

    collaborator OTHER

  • CorMatrix Cardiovascular, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Matheny, MD · CorMatrix Cardiovascular, Inc.

  • Brad Solberg, MBA · Veranex

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-10
Primary Completion
2025-12-31
Completion
2026-12-31
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 NCT05742906 on ClinicalTrials.gov