Acute Cardiac DysfunctionPhase 3NCT00971776
Voyager I: Patient Discharge Using the AB5000 Portable Driver System
A Phase 3 study testing AB Portable Driver System in people with Acute Cardiac Dysfunction, run by Abiomed Inc..
Trial 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 receive the assistance of the AB 5000 ventricle for their heart recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Cardiac Dysfunction
- What is being tested?
- AB Portable Driver System
- Type of treatment
- Medical device
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Sep 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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.
- Conditions
- Acute Cardiac Dysfunction
- Being tested
- AB Portable Driver System
- Keywords
- Patient receiving AB5000 ventricle potentially recoverable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB Portable Driver SystemDevice
Evaluate the safety and performance of the AB Portable Driver System in home environment.
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, Quality of life assessment, NIH Stroke Scale Assessments, and patient outcome after readmission
Measured: Pre-discharge, 30 days post-discharge, 90 days or re-admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startJun 2008
- Primary completionApr 2013
- Study completionSep 2013 (estimated)
Why it stopped: Terminated due to slow enrollment and change in business priority
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Cardiac DysfunctionStudies of the same condition, open and under way.
- More trials run by Abiomed Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abiomed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971776
- Sponsor's protocol ID
- Voyager I: G80013/S001
- Status last verified
- May 2013
- First submitted
- 2 Sep 2009
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voyager I: Patient Discharge Using the AB5000 Portable Driver System
- ClinicalTrials.gov ID
- NCT00971776
- Acronym / sponsor ID
- Voyager I: G80013/S001
- Conditions
- Acute Cardiac Dysfunction
- Keywords
- Patient receiving AB5000 ventricle potentially recoverable
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to slow enrollment and change in business priority
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Abiomed Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Apr 2013 (actual)
- Study completion
- Sep 2013 (estimated)
- First posted
- 4 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AB Portable Driver SystemEvaluate the safety and performance of the AB Portable Driver System in home environment. | Device | – |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Terminated due to slow enrollment and change in business priority). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AB Portable Driver System in people with Acute Cardiac Dysfunction, run by Abiomed Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 May 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Terminated due to slow enrollment and change in business priority). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2013.