A Study of the Experimental CorMatrix Cor TRICUSPID ECM Device for Tricuspid Valve Replacement

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Age: 1 to 70 years old
Gender:
Any
Healthy Volunteers: No
Keywords: tricuspid valve replacement, heart valve
Type: Device study
Target:
5 Participants
Investigator:
Description
This study will determine if the experimental Cor TRICUSPID ECM Valve is a safe replacement of your natural Tricuspid Valve.

This is an Early Feasibility Study. That means that it is a small study of a new kind of device. It has only been implanted in a limited number of human subjects. There may be less nonclinical information and testing than would be required to start a larger study.

The study is designed to gain initial insights into the basic safety and functionality of the study device.

Participation in this study will involve placement of the experimental device Cor TRICUSPID ECM Valve. It will replace your dysfunctional tricuspid heart valve. Over time, the design of the CorMatrix Cor TRICUSPID ECM Valve may allow your own cells to grow into and reconstruct the tricuspid valve structure. This will result in long-term tissue repair with your own natural tissue.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

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
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
You will make 4 visits to the clinic after your procedure. You will then have annual visits for about 5 years.
Recruitment period
From March 19, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Lynda Painting
Research Topic
Conditions:
  • Tricuspid Valve Disease