Status:
TERMINATED
Voyager I: Patient Discharge Using the AB5000 Portable Driver System
Lead Sponsor:
Abiomed Inc.
Conditions:
Acute Cardiac Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00971776
Start Date
June 1 2008
End Date
September 1 2013
Last Update
May 3 2013
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.