RECRUITING

CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study

Conditions

Tricuspid Valve Disease Tricuspid Valve Insufficiency Tricuspid Valve Dysfunction Tricuspid Valve Regurgitation Tricuspid Valve Replacement

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

CorMatrix® Cor™ TRICUSPID ECM® Valve Replacement Study

Quick Facts

Study Start:2022-08-10

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05742906

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Patient with a regurgitant or absent tricuspid valve requiring surgical treatment including those patients having concomitant cardiac procedures 2. 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 3. 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 4. Patients where the Cor TRICUSPID ECM Valve will be the physiological right-sided atrioventricular (AV) valve	1. Tricuspid annulus too small (\< 10mm) to accommodate the Cor TRICUSPID ECM Valve 2. Left ventricular ejection fraction (LVEF) \< 25% 3. Mean pulmonary pressure ≥ 50mmHg 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

Inclusion Criteria

Exclusion Criteria

1. Patient with a regurgitant or absent tricuspid valve requiring surgical treatment including those patients having concomitant cardiac procedures
2. 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
3. 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
4. Patients where the Cor TRICUSPID ECM Valve will be the physiological right-sided atrioventricular (AV) valve

1. Tricuspid annulus too small (\< 10mm) to accommodate the Cor TRICUSPID ECM Valve
2. Left ventricular ejection fraction (LVEF) \< 25%
3. Mean pulmonary pressure ≥ 50mmHg 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

Contacts and Locations

Study Contact

Robert G Matheny, MD

CONTACT

404-276-7777

Rmatheny@Cormatrix.com

Brad Solberg, MBA

CONTACT

4084644001

brad@experiengroup.com

Principal Investigator

Robert Matheny, MD

STUDY_DIRECTOR

CorMatrix Cardiovascular, Inc.

Brad Solberg, MBA

STUDY_DIRECTOR

Veranex

Study Locations (Sites)

St Francis Hospital

Indianapolis, Indiana, 46237

United States

Columbia University Irving Medical Center/New York Presbyterian

New York, New York, 10032

United States

Collaborators and Investigators

Sponsor: CorMatrix Cardiovascular, Inc.

Robert Matheny, MD, STUDY_DIRECTOR, CorMatrix Cardiovascular, Inc.
Brad Solberg, MBA, STUDY_DIRECTOR, Veranex

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-10

Study Completion Date2024-12

Study Record Updates

Study Start Date2022-08-10

Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

Tricuspid Valve Disease
Tricuspid Valve Dysfunction
Tricuspid Valve Regurgitation
Tricuspid Valve Replacement

Additional Relevant MeSH Terms

Tricuspid Valve Disease
Tricuspid Valve Insufficiency