Lead Sponsor

Terumo Heart Inc.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•The following are general criteria; more specific conditions are included in the study protocol:
•1. Approved for cardiac transplantation
•2. Listed with UNOS on the Status 1 list
•3. Patient for whom LVAS implantation is planned as a clinically indicated bridge to cardiac transplantation

•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