Voyager I: Patient Discharge Using the AB5000 Portable Driver System

Abiomed

Status and phase: Terminated; Phase 3

Conditions: Acute Cardiac Dysfunction

Treatments: Device: AB Portable Driver System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00971776

Voyager I: G80013/S001

Details and patient eligibility

About

The AB Portable Driver System will allow patients supported with the Circulatory Support System to be discharged home when their medical condition improves to an ambulating status and will continue to receive the assistance of the AB 5000 ventricle for their heart recovery.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)