CorMatrix Cor TRICUSPID ECM Valve Replacement Study

NCT02397668 | Recruiting DMC FDA Device

• 1 other identifier: 14-PR-1101 Rev. L
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 4

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.

Conditions

Tricuspid Valve Disease

Outcome Measures

Primary Outcomes (1)

• Procedural Success

  Device Success and No TV device- or TV procedure-related SAE's

  30 days postop

Secondary Outcomes (2)

• Device Success

  30 day and all follow up time points

• Technical Success

  within 24 hours

Study Arms (1)

CorMatrix Cor TRICUSPID ECM Valve

EXPERIMENTAL

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.

Device: CorMatrix Cor TRICUSPID ECM Valve

Interventions

CorMatrix Cor TRICUSPID ECM Valve DEVICE

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

Also known as: Cor PEDIATRIC Tricuspid ECM Valve

CorMatrix Cor TRICUSPID ECM Valve

Eligibility Criteria

• Age: 1 Year - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with a regurgitant or absent tricuspid valve requiring surgical treatment including those patients having concomitant cardiac procedures
• Male or female
• 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
• 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
• Children with congenital disease where the Cor PEDIATRIC Tricuspid ECM Valve would be the physiological right-sided valve

You may not qualify if:

• Tricuspid annulus too small (\< 10mm) to accommodate the Cor Tricuspid ECM Valve
• Left ventricular ejection fraction (LVEF) \< 25%
• Mean pulmonary pressure \> 50mm Hg or pulmonary vascular resistance greater than 6 Woods Units
• Emergency cardiac procedure. An example would be a person requiring resuscitation and in cardiogenic shock. An unscheduled or unplanned emergency surgery
• Cardiac transplant patient
• Acute transmural myocardial infarction (MI) within 7 days of enrollment that results in cardiogenic shock
• Patients with a single ventricle where the Cor Tricuspid ECM Valve would be the systemic AV valve
• 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
• 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)
• Documented evidence of significant renal dysfunction (serum creatinine \> 4.0mg/dl or GFR\< 30 on the modified Schwartz formula)
• Stroke within 30 days prior to enrollment
• Major or progressive non-cardiac disease (liver failure, renal failure, cancer (CA)) that has a life expectancy of less than one year
• 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
• Hematological disorders (e.g., aplastic anemia) or patients taking bone marrow suppressant drugs
• Known sensitivity to porcine materials

Sponsors & Collaborators

• Corvivo Cardiovascular, Inc.: lead

Study Sites (4)

Springhill Memorial Hospital

Mobile, Alabama, 36607, United States

RECRUITING

St Francis Hospital

Indianapolis, Indiana, 46237, United States

RECRUITING

Medstar

Baltimore, Maryland, 21244, United States

RECRUITING

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

RECRUITING

Study Officials

• Robert G Matheny, MD

  Corvivo Cardiovascular, Inc.

  STUDY DIRECTOR

Central Study Contacts

Robert G Matheny, MD

CONTACT

404-276-7777; rmatheny@cormatrix.com

Rhonda B Van Genderen, RN, MBA

CONTACT

715-441-5411; Rvangenderen@cormatrix.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-center, prospective, single-arm, Pivotal study of subjects receiving the Cor TRICUSPID ECM Valve or Cor PEDIATRIC Tricuspid ECM Valve

Study Record Dates

• First Submitted: March 6, 2015
• First Posted: March 25, 2015
• Study Start: August 1, 2022
• Primary Completion: December 15, 2025
• Study Completion (Estimated): December 15, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)