CorMatrix Cor TRICUSPID ECM valve for replacing the tricuspid valve

CorMatrix Cor TRICUSPID ECM Valve Replacement Study

This will try a surgical heart valve called the CorMatrix Cor TRICUSPID ECM in adults and children who need tricuspid valve replacement.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 1 Year to 85 Years
• Sex: All
• Sponsor: Corvivo Cardiovascular, Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 4 sites (Mobile, Alabama and 3 other locations)
• Trial ID: NCT02397668 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm, multi-center Pivotal trial in which eligible patients will undergo surgical tricuspid valve replacement with the CorMatrix Cor TRICUSPID ECM Valve (with a pediatric-sized Cor PEDIATRIC option where appropriate). Up to 60 subjects will be enrolled across up to 15 U.S. sites, with provisions for pediatric patients within the cohort. The study will track successful implantation, clinical safety endpoints, and valve performance over scheduled follow-up visits. Enrollment includes patients with regurgitant or absent tricuspid valves and allows concomitant cardiac procedures when indicated.

Who should consider this trial

Good fit: Adults and children who require surgical replacement of a regurgitant or absent tricuspid valve, including those having concomitant cardiac procedures and pediatric congenital cases appropriate for the pediatric valve.

Not a fit: Patients with a tricuspid annulus under 10 mm, left ventricular ejection fraction below 25%, or mean pulmonary artery pressure over 50 mmHg are excluded and unlikely to benefit from this device.

Why it matters

Potential benefit: If successful, the device could provide a tissue-based valve option that restores tricuspid valve function in adults and children and may reduce the need for repeat operations.

How similar studies have performed: An earlier early-feasibility cohort supported implantation of the Cor TRICUSPID ECM valve, and this Pivotal trial builds on those preliminary data though long-term, large-scale outcomes remain limited.

Eligibility criteria

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

Where this trial is running

Mobile, Alabama and 3 other locations

• Springhill Memorial Hospital — Mobile, Alabama, United States (Recruiting)
• St Francis Hospital — Indianapolis, Indiana, United States (Recruiting)
• Medstar — Baltimore, Maryland, United States (Recruiting)
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: Robert G Matheny, MD

Conditions Tricuspid Valve Disease