Replacement of dysfunctional tricuspid valves using a new ECM valve

CorMatrix® Cor™ TRICUSPID ECM® Valve Replacement Study

This study is testing a new valve to see if it can safely replace faulty tricuspid valves in both adults and children.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sex: All
• Sponsor: Corvivo Cardiovascular, Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Indianapolis, Indiana and 1 other locations)
• Trial ID: NCT05742906 on ClinicalTrials.gov

What this trial studies

This pivotal study aims to evaluate the safety and effectiveness of the Cor TRICUSPID ECM Valve for replacing dysfunctional tricuspid valves in both adult and pediatric patients. Participants will undergo a preoperative evaluation followed by the surgical implantation of the valve, with subsequent postoperative assessments at various intervals up to five years. The study seeks to determine whether the device can be safely implanted and effectively treat tricuspid valve disease and dysfunction. The data collected will support a Humanitarian Device Exemption application for the valve.

Who should consider this trial

Good fit: Ideal candidates include patients with regurgitant or absent tricuspid valves requiring surgical intervention, including those needing additional cardiac procedures.

Not a fit: Patients with a tricuspid annulus too small to accommodate the valve or severely compromised heart function may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients suffering from tricuspid valve disease, potentially improving their quality of life and surgical outcomes.

How similar studies have performed: While this approach is novel, similar studies involving heart valve replacements have shown promising results, indicating potential for success.

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

Where this trial is running

Indianapolis, Indiana and 1 other locations

• St Francis Hospital — Indianapolis, Indiana, United States (Recruiting)
• Columbia University Irving Medical Center/New York Presbyterian — New York, New York, United States (Recruiting)

Study contacts

• Study coordinator: Robert G Matheny, MD

Conditions Tricuspid Valve Disease; Tricuspid Valve Insufficiency; Tricuspid Valve Dysfunction; Tricuspid Valve Regurgitation; Tricuspid Valve Replacement