- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00971776
Voyager I: Patient Discharge Using the AB5000 Portable Driver System
May 1, 2013 updated by: Abiomed Inc.
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 Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Pre-discharge, 30 days post-discharge, 90 days or re-admission
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
April 1, 2013
Study Completion (Anticipated)
September 1, 2013
Study Registration Dates
First Submitted
September 2, 2009
First Submitted That Met QC Criteria
September 3, 2009
First Posted (Estimate)
September 4, 2009
Study Record Updates
Last Update Posted (Estimate)
May 3, 2013
Last Update Submitted That Met QC Criteria
May 1, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- Voyager I: G80013/S001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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