CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study

Launched by CORMATRIX CARDIOVASCULAR, INC. · Feb 14, 2023

Keywords

ClinConnect Summary

The CorMatrix Cor TRICUSPID ECM Valve Replacement study is looking at a new valve designed to help people with tricuspid valve disease, which means their heart’s tricuspid valve is not working properly. This trial aims to see if the Cor TRICUSPID ECM Valve can be safely and effectively used for surgery in both adults and children. Researchers want to find out if the valve can be successfully implanted and if it improves patients' conditions over the course of a year after the surgery.

To be part of the study, participants must have a tricuspid valve that is either leaking or not functioning, and they need to be ready for surgery. They also need to understand what the study involves and agree to follow-up appointments after the surgery. Participants will have evaluations before and after the surgery, including check-ups at the hospital, 30 days later, and again at 6 months, 12 months, and yearly for up to 5 years. However, some people won't be able to join the study, such as those with very serious heart problems or other major health issues.

Gender

ALL

Eligibility criteria

• Inclusion 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
• 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 ≥ 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