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)
First Posted: September 4, 2009
Last Update Posted: May 3, 2013
Information provided by (Responsible Party):
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
|Official Title:||Voyager I: Patient Discharge Using the AB5000 Portable Driver System|
Further study details as provided by Abiomed Inc.:
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 ]
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||September 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Device: AB Portable Driver System
Evaluate the safety and performance of the AB Portable Driver System in home environment.
Contacts and Locations
No Contacts or Locations Provided