Biventricular FailureNCT00733447
SynCardia Freedom Driver System Study
A study testing CardioWest temporary Total Artificial Heart (TAH-t) System in people with Biventricular Failure, run by SynCardia Systems. LLC at 3 sites in United States.
Trial summary
The purposes of this study are to confirm that the Freedom Driver System is a suitable pneumatic driver for clinically stable TAH-t subjects, and that patients and lay caregivers can be trained to manage the Freedom Driver System safely outside the hospital. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Biventricular Failure
- What is being tested?
- CardioWest temporary Total Artificial Heart (TAH-t) System
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 3 sitesUnited States
- Study dates
- Mar 2010to May 2014
- Phase
- Expanded access
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who are implanted with the TAH-t and are clinically stable.
Who cannot join
- Patients who are implanted with the TAH-t and are not clinically stable.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic Hospital
Phoenix, Arizona, 85054
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298
About this study
The purposes of this study are to confirm that the Freedom Driver System is a suitable pneumatic driver for clinically stable TAH-t subjects, and that patients and lay caregivers can be trained to manage the Freedom Driver System safely outside the hospital.
- Conditions
- Biventricular Failure
- Being tested
- CardioWest temporary Total Artificial Heart (TAH-t) System
- Keywords
- Biventricular failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioWest temporary Total Artificial Heart (TAH-t) SystemDevice
The SynCardia CardioWest temporary Total Artificial Heart (TAH-t) System is a pulsatile biventricular device that replaces a patient's native ventricles and valves, and pumps blood to both pulmonary and systemic circulation. The system consists of the implantable CardioWest TAH-t and an external pneumatic driver connected by drivelines.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2008 (estimated)
- Study startMar 2010
- Primary completionAug 2013
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biventricular FailureStudies of the same condition, open and under way.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- SynCardia Systems. LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00733447
- Sponsor's protocol ID
- RA-142
- Other IDs
- P030011
- Status last verified
- Jul 2015
- First submitted
- 11 Aug 2008
- Last updated
- 30 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SynCardia Freedom Driver System Study
- ClinicalTrials.gov ID
- NCT00733447
- Acronym / sponsor ID
- RA-142
- Conditions
- Biventricular Failure
- Keywords
- Biventricular failure
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- SynCardia Systems. LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- May 2014 (estimated)
- First posted
- 13 Aug 2008 (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 purposes of this study are to confirm that the Freedom Driver System is a suitable pneumatic driver for clinically stable TAH-t subjects, and that patients and lay caregivers can be trained to manage the Freedom Driver System safely outside the hospital.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are implanted with the TAH-t and are clinically stable.
Key exclusion criteria (1 listed)
- Patients who are implanted with the TAH-t and are not clinically stable.
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 |
|---|---|---|
| CardioWest temporary Total Artificial Heart (TAH-t) SystemThe SynCardia CardioWest temporary Total Artificial Heart (TAH-t) System is a pulsatile biventricular device that replaces a patient's native ventricles and valves, and pumps blood to both pulmonary and systemic circulation. The system consists of the implantable CardioWest TAH-t and an external pneumatic driver connected by drivelines. | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CardioWest temporary Total Artificial Heart (TAH-t) System in people with Biventricular Failure, run by SynCardia Systems. LLC at 3 sites in United States.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
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.
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 30 Jul 2015.