Voyager I: Patient Discharge Using the AB5000 Portable Driver System
This study has been terminated.
(Terminated due to slow enrollment and change in business priority)
Information provided by (Responsible Party):
First received: September 2, 2009
Last updated: May 1, 2013
Last verified: May 2013
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.
Acute Cardiac Dysfunction
Device: AB Portable Driver System
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
||Voyager I: Patient Discharge Using the AB5000 Portable Driver System
Primary Outcome Measures:
- Adverse events, Quality of life assessment, NIH Stroke Scale Assessments, and patient outcome after readmission [ Time Frame: Pre-discharge, 30 days post-discharge, 90 days or re-admission ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||April 2013 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
No Contacts or Locations Provided
No publications provided
History of Changes
|Other Study ID Numbers:
||Voyager I: G80013/S001
|Study First Received:
||September 2, 2009
||May 1, 2013
||United States: Food and Drug Administration
Keywords provided by Abiomed Inc.:
ClinicalTrials.gov processed this record on March 09, 2014
Patient receiving AB5000 ventricle potentially recoverable