Voyager I: Patient Discharge Using the AB5000 Portable Driver System

Inclusion Criteria:

• The subject is an AB5000 Circulatory Support System patient (in accordance FDA-approved indications for use) who is suffering acute cardiac dysfunction and is potentially recoverable;
• The subject is male or female, age 18 years or older;
• The subject is able to ambulate unassisted;
• The subject is on stable oral anticoagulation over 7 days (INR 2-4) with no active bleeding;
• The subject is willing and able to read, understand and sign the study specific informed consent form;
• The subject agrees to comply with study protocol requirements, including all follow-up visits and completion of Qol and NIH stroke scale assessments.

Exclusion Criteria:

• The subject, pre-device implant, is qualified as a transplant candidate.
• There is an absence of a trained companion.
• There is an absence of a psycho-social support.
• The subject has an inadequate home environment, such as poor access which may hinder movements.
• The subject has experienced hypotension in last 24 hours based on two consecutive readings spaced by 8 hours with systolic blood pressures < 90 mmHg.
• The subject requires respiratory assistance.
• The subject has an active infection (positive blood culture and/or body T ≥ 38 degrees C, and/or WBC ≥ 12K/µL).
• The subject requires tube feeding.
• The subject has any other medical condition requiring hospitalization.