CorMatrix Cor TRICUSPID ECM Valve Replacement Study

NCT ID: NCT02397668

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2026-12-15

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CorMatrix Cor TRICUSPID ECM Valve

Tricuspid valve replacement in patients for the surgical management of tricuspid valve disease, including tricuspid valve disease secondary to congenital heart disease. Enrollment will include up to 60 adults subjects and up to 18 pediatric subjects.

Group Type: EXPERIMENTAL

CorMatrix Cor TRICUSPID ECM Valve

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Cor PEDIATRIC Tricuspid ECM Valve

Eligibility Criteria

Inclusion Criteria

1. Patient with a regurgitant or absent tricuspid valve requiring surgical treatment including those patients having concomitant cardiac procedures

2. Male or female

3. Patient/authorized legal guardian understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provides written informed consent and the pediatric patient (if applicable) provides written assent (if able) prior to procedure

4. Patient/patient's authorized legal guardian is geographically stable (or willing to return for required study follow-up) and understands and is willing to fulfill all of the expected requirements of this clinical protocol

5. Children with congenital disease where the Cor PEDIATRIC Tricuspid ECM Valve would be the physiological right-sided valve

Exclusion Criteria

1. Tricuspid annulus too small (< 10mm) to accommodate the Cor Tricuspid ECM Valve

2. Left ventricular ejection fraction (LVEF) < 25%

3. Mean pulmonary pressure > 50mm Hg or pulmonary vascular resistance greater than 6 Woods Units

4. Emergency cardiac procedure. An example would be a person requiring resuscitation and in cardiogenic shock. An unscheduled or unplanned emergency surgery

5. Cardiac transplant patient

6. Acute transmural myocardial infarction (MI) within 7 days of enrollment that results in cardiogenic shock

7. Patients with a single ventricle where the Cor Tricuspid ECM Valve would be the systemic AV valve

8. Documented primary coagulopathy or uncorrected platelet disorder, including thrombocytopenia (absolute platelet count <30k). Patient can be enrolled regardless of these parameters if in the opinion of the Investigating Surgeon the coagulopathy can be adequately reversed by transfusions. An example would be the reversal of thrombocytopenia by transfusion of platelets

9. Documented evidence of intrinsic hepatic disease (defined as liver enzyme values (aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin) that are > 5 times the upper limit of reference range within 30 days of enrollment, except in association with acute/reversible decompensation as determined by the Investigator)

10. Documented evidence of significant renal dysfunction (serum creatinine > 4.0mg/dl or GFR< 30 on the modified Schwartz formula)

11. Stroke within 30 days prior to enrollment

12. Major or progressive non-cardiac disease (liver failure, renal failure, cancer (CA)) that has a life expectancy of less than one year

13. Known cancer (cancer-free <1 year; does not include non-metastatic basal cell carcinoma or cervical carcinoma) and/or undergoing treatment including chemotherapy and radiotherapy

14. Hematological disorders (e.g., aplastic anemia) or patients taking bone marrow suppressant drugs

15. Known sensitivity to porcine materials

16. Contraindication to anticoagulation/antiplatelet therapy (aspirin (ASA) and/or Plavix)

17. Patients who are pregnant (method of assessment Investigator's discretion)

18. Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study, without CorMatrix written approval

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CorMatrix Cardiovascular, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert G Matheny, MD

Role: STUDY_DIRECTOR

CorMatrix Cardiovascular, Inc.

Locations

Springhill Memorial Hospital

Mobile, Alabama, United States

Site Status: RECRUITING

St Francis Hospital

Indianapolis, Indiana, United States

Site Status: RECRUITING

Medstar

Baltimore, Maryland, United States

Site Status: RECRUITING

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Robert G Matheny, MD

Role: CONTACT

rmatheny@cormatrix.com

404-276-7777

Rhonda B Van Genderen, RN, MBA

Role: CONTACT

Rvangenderen@cormatrix.com

715-441-5411

Facility Contacts

Brian Bethea, MD

Role: primary

Other Identifiers

14-PR-1101 Rev. L

Identifier Type: -

Identifier Source: org_study_id