A Study of VentriGel in Post-MI Patients

Evaluate the safety and feasibility of VentriGel delivered trans-endocardially to subjects with left ventricular ejection fraction (LVEF) 25 to 45% secondary to MI. Secondary endpoints will look at efficacy variables of ESV, EDV, EF, scar mass.

Inclusion criteria

• The subject is 30-75 years of age
• The subject must be able to provide informed consent
• At least 60 days and no more than 3 years will have passed since the first ST elevation myocardial infarction (Index STEMI) at time of VentriGel administration
• The Index STEMI must meet the following criteria:

• First time diagnosis of STEMI AND;
• Meet the STEMI criteria of the American College of Cardiology (ACC)/American Heart Association (AHA) (e.g. ST elevation in at least 2 contiguous leads >0.2 mV in V1, V2 or V3 and/or >0.1mV in at least two other leads), or new left bundle branch block (LBBB)
• Evidence of left ventricular remodeling secondary to the myocardial infarction using 2-D echocardiography or cMR;

• the LVEF must be ≥ 25% and ≤ 45% AND;
• The left ventricular wall thickness is ≥ 8 mm in target area.
• Successful percutaneous coronary intervention (PCI) restoring TIMI II of higher flow to infarcted area
• Negative pregnancy test [serum human chorionic gonadotropin (βhCG)] in women of childbearing potential within 24 hours prior to dosing) or if less than 2 years postmenopausal agree to use of adequate contraception during the study.
• Must be ambulatory, willing and able to comply with protocol, including follow-up visits
• Subject must be receiving best medical treatment for their post-MI clinical presentation according to the American College of Cardiology (ACC)/American Heart Association (AHA) guidelines
• For those subjects indicated for heart failure medical therapy, subjects must be on stable therapy including beta-blockers and angiotensin converting enzyme inhibitors, if tolerated, for at least 45 days prior to therapy delivery

Exclusion criteria

• Contraindications to cardiac MR
• NYHA Functional Classification 4 heart failure within the prior 6 months.
• Significant coronary artery stenosis that may require percutaneous or surgical revascularization within six months of enrollment, as determined by the principal investigator
• 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
• Frequent, recurrent, sustained (>30 seconds) ventricular tachycardia in 30 days prior to VentriGel administration
• 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)
• Atrial fibrillation with heart rate greater than 110 bpm.
• Severe valvular disease (e.g. aortic stenosis of moderate or worse severity, valvular insufficiency requiring surgical repair) or history of heart valve replacement.
• Known allergy to porcine proteins or prior implantation of a porcine derived medical product including cardiac valves or other ECM products.
• 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.
• Severe peripheral vascular disease that impairs femoral arterial access.
• Less than 3 years, cancer free, since end of treatment for cancer (with exception of basal cell carcinoma)
• Alcohol or drug dependency within six months prior to enrollment
• Cerebrovascular event within the 90 days prior or major surgical procedure or major trauma within the 14 days prior to enrollment
• 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)
• Uncontrolled hypertension defined as systolic blood pressure (SBP) > 180 mmHg and/or or diastolic blood pressure (DBP) >110 mmHg
• 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
• 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.
• Institutional interpretation of cMR EF data outside the ≥ 25% and ≤ 45% limits