The following are general criteria; more specific conditions are included in the study protocol:

1. Contraindication to the administration of warfarin or anti-platelet agents

2. Primary coagulopathy or platelet disorder

3. Acute myocardial infarction within 48 hours prior to enrollment

4. Anticipated need for RVAD support or ECMO at the time of LVAS implantation

5. Prior cardiac transplantation, left ventricular reduction surgery, cardiomyoplasty, passive restraint device (i.e., CorCapTM Cardiac Support Device) or surgically implanted left ventricular assist device

Evaluation of the Safety and Effectiveness of the DuraHeart™ LVAS

What this study is about