Myocardial Infarction; Heart Failure; Left Ventricular Remodeling
Evaluate the safety and feasibility of investigational VentriGel delivered via endomyocardial injections using NOGA mapping/Myostar catheter 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.
CRITERIA LIST/ QUALIFICATIONS:
- The subject is 30-75 years of age.
- At least 60 days and no more than 3 years will have passed since prior acute myocardial infarction (AMI) at time of VentriGel administration.
- The AMI must meet the following criteria:
- First time diagnosis of myocardial infarction AND
- Meet the STEMI criteria of the American College of Cardiology (ACC)/American Heart Association (AHA) (e.g. ST elevation in at least 2 leads >0.2 mV in V1, V2 or V3 or >0.1mV in other leads in at least two anterior 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.
Jay Traverse, MD