Ensayos clínicos

Inclusion Criteria:

• Patient with a regurgitant or absent tricuspid valve that is not amenable to annuloplasty or repair
• Male or female <21 years of age and in the Investigator's opinion able to withstand tricuspid valve surgery (pediatric only)
• 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 patient provides written assent (if able) prior to procedure
• Patient 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
• Patient with tricuspid endocarditis or endocarditis in another heart valve (endocarditis only)
• Male or female age 2 to 70 years (endocarditis only)

Exclusion Criteria:

1. Tricuspid annulus too small (< 14mm) to accommodate the CorMatrix ECM Tricuspid Valve
2. Left ventricular ejection fraction (LVEF) < 30%
3. Mean pulmonary pressure > 45mm Hg
4. Previous cardiac surgical procedures (does not exclude a redo of isolated tricuspid valve surgery)
5. Emergency cardiac procedure
6. Acute myocardial infarction within 30 days of enrollment
7. Patients with severe right ventricular dysfunction (severe hypokinesis)
8. Patients with a single ventricular valve
9. Patients with active endocarditis (any valve within one year) (Pediatric only)
10. Documented primary coagulopathy or platelet disorder, including thrombocytopenia (absolute platelet count <80k)
11. Documented evidence of intrinsic hepatic disease (defined as liver enzyme values (AST, ALT or total bilirubin) that are > 5 times the upper limit of reference range within 30 days of enrollment, except in association with acute decompensation as determined by the Investigator)
12. Documented Hepatitis C
13. Documented evidence of significant renal dysfunction (serum creatinine > 2.5mg/dl) or on any form of dialysis at time of screening
14. Active infection within one week of enrollment (patients on antibiotic treatment < 7 days prior to enrollment)
15. Stroke within 90 days prior to enrollment, or a history of cerebral vascular disease with significant (> 80%) extra cranial stenosis (patients with CVD history documented by a carotid Doppler study)
16. Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year
17. Known cancer (cancer-free < 5 years; does not include non-metastatic basal cell carcinoma or cervical carcinoma) and/or undergoing treatment including chemotherapy and radiotherapy
18. Hematological disorders (e.g., aplastic anemia), bone marrow disorders, connective tissue disease (lupus), patients taking bone marrow suppressant drugs
19. Patients with a lead or wire through the tricuspid valve into the right ventricle
20. Documented human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
21. Psychiatric or behavioral disease (including drug or alcohol abuse and antisocial disorder) that is likely to impair compliance with the study protocol. (Must document zero non-prescription drug or alcohol use > 1 year, if previous drug or alcohol abuse)
22. Known sensitivity to porcine materials
23. Contraindication to anticoagulation/antiplatelet therapy (ASA or Plavix)
24. Patients who are pregnant (method of assessment Investigator's discretion)
25. 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