A Study of VentriGel in Post-MI Patients

Exclusion Criteria

• •1. Contraindications to cardiac MR
• •2. NYHA Functional Classification 4 heart failure within the prior 6 months.
• •3. Significant coronary artery stenosis that may require percutaneous or surgical revascularization within six months of enrollment, as determined by the principal investigator
• •4. Left ventricular thrombus, left ventricular aneurysm, subjects with post-infarction pericarditis, or subjects with wall motion abnormalities outside the region of the infarct related artery
• •5. Frequent, recurrent, sustained (\>30 seconds) ventricular tachycardia in 30 days prior to VentriGel administration
• •6. ECG or 24 hour Holter Monitor with any of the following findings:
• •* Bifascicular block (left bundle branch block or right bundle branch block plus left hemi-block)
• •* Higher grade AV block (i.e. 3rd degree)
• •* Ventricular tachycardia (\>= 5 seconds of VT OR any symptomatic VT)
• •7. Atrial fibrillation with heart rate greater than 110 bpm.
• •8. Severe valvular disease (e.g. aortic stenosis of moderate or worse severity, valvular insufficiency requiring surgical repair) or history of heart valve replacement.
• •9. Known allergy to porcine proteins or prior implantation of a porcine derived medical product including cardiac valves or other ECM products.
• •10. Etiology of heart failure due to any cause (e.g. hypertrophic cardiomyopathies, restrictive cardiomyopathies, constrictive pericardial disease, amyloidosis, active myocarditis) other than the index MI.
• •11. Severe peripheral vascular disease that impairs femoral arterial access.
• •12. Less than 3 years, cancer free, since end of treatment for cancer (with exception of basal cell carcinoma)
• •13. Alcohol or drug dependency within six months prior to enrollment
• •14. Cerebrovascular event within the 90 days prior or major surgical procedure or major trauma within the 14 days prior to enrollment
• •15. Participation, defined as receiving test article, in an experimental clinical study within 30 days prior to administration of VentriGel (i.e. screen failure from other study does not exclude subject)
• •16. Uncontrolled hypertension defined as systolic blood pressure (SBP) \> 180 mmHg and/or or diastolic blood pressure (DBP) \>110 mmHg
• •17. Abnormal laboratory values as defined below performed at screening:
• •* Aspartate aminotransferase \[AST\]/ alanine aminotransferase \[ALT\] ≥ 3 times upper limit of normal (ULN)
• •* Serum creatinine ≥ 2.0 mg/dL
• •* Platelet count \< 50,000/mm3
• •* Hemoglobin \< 9.0 g/dL
• •* HbA1c \> 9.0%
• •* PT or aPTT with clinically significant elevations relative to local laboratory norms
• •18. Any other cardiac or non-cardiac conditions or illness which, in the opinion of the principal investigator, may place subjects at undue risk or compromise the objectives of the study.
• •19. Institutional interpretation of cMR EF data outside the ≥ 25% and ≤ 45% limits