AB Portable Driver System in the Outpatient Environment

The purpose of this study is to collect clinical data on the use of the AB5000 Portable Driver System.  AB5000 is approved for use in patients suffering from reversible ventricular dysfunction.  However its use is limited to the hospital environment.  The Portable Driver System may potentially allow patients supported with AB5000 to be discharge out of the hospital.  

Dzifa Dordunoo, MSN, RN
Email: edordun1@jhmi.edu
(410) 955-3597

Tamara Bubb, BS
Email:  tbubb1@jhmi.edu
(410) 502-5438

A multi-center, prospective, single arm clinical trial designed to evaluate the safety and performance of the AB Portable Driver System in the outpatient environment (VOYAGER)

The patient is currently on an AB5000 Circulatory Support System (in accordance FDA-approved indications for use) who is suffering acute cardiac dysfunction and is potentially recoverable.

• The patient is male or female, age 18 years or older
• The patient is able to ambulate unassisted
• The patient is on stable oral anticoagulation over 7 days (INR: 2-4) with no active bleeding
• The patient is willing and able to read, understand and sign the study specific informed consent form
• Agrees to comply with study protocol requirements, including all follow-up visits and completion of

Exclusions: 

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

Johns Hopkins Hospital
600 North Wolfe Street, Blalock 618
Baltimore, MD 21287-4618

This is a multi-center study.