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Clinical Trials in the USA / NCT02397668
Recruiting Not applicable

CorMatrix Cor TRICUSPID ECM Valve Replacement Study

NCT02397668 · tracked via the Priya Life Science USA tracker
Sponsor
Corvivo Cardiovascular, Inc.
Phase
Not applicable
Started
2022-08-01
Last updated
2025-09-02

Condition(s) studied

Tricuspid Valve Disease

Investigational drug(s) / intervention(s)

CorMatrix Cor TRICUSPID ECM Valve

CorMatrix Cor TRICUSPID ECM Valve: CorMatrix Cor TRICUSPID ECM Valve to replace a diseased tricuspid valve, including tricuspid valve disease secondary to congenital heart disease.

Study summary

The Pivotal Study of the Cor TRICUSPID ECM Valve (or Cor PEDIATRIC Tricuspid ECM Valve). This study follows the EFS and is now to determine the safety and efficacy of the Cormatrix Cor TRICUSPID Valve for any patients requiring surgical replacement of the tricuspid valve.

Eligibility

Sex
ALL
Min age
1 Year
Max age
85 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Springhill Memorial Hospital Mobile Alabama Recruiting
St Francis Hospital Indianapolis Indiana Recruiting
Medstar Baltimore Maryland Recruiting
Cincinnati Children's Hospital Cincinnati Ohio Recruiting

More Corvivo Cardiovascular, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02397668 on ClinicalTrials.gov ↗ ← All trials in the USA