SynCardia Freedom Driver System Study
This study is currently recruiting participants.
Verified June 2012 by SynCardia Systems. Inc.
Sponsor:
SynCardia Systems. Inc.
Information provided by (Responsible Party):
SynCardia Systems. Inc.
ClinicalTrials.gov Identifier:
NCT00733447
First received: August 11, 2008
Last updated: June 8, 2012
Last verified: June 2012
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | August 11, 2008 | ||||||||
| Last Updated Date | June 8, 2012 | ||||||||
| Start Date ICMJE | March 2010 | ||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Freedom Driver is a suitable pneumatic driver for clinically stable TAH-t subjects. [ Time Frame: Transplant, 90 days or death ] [ Designated as safety issue: Yes ] Transplant, 90 days of support from date of discharge, 90 days of in-hospital support for subjects who are not discharged, or death |
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| Original Primary Outcome Measures ICMJE |
Companion Driver is a suitable replacement for the CSS Console. [ Time Frame: Transplant, 180 days or death ] [ Designated as safety issue: Yes ] | ||||||||
| Change History | Complete list of historical versions of study NCT00733447 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Freedom Driver can be safely used at home. [ Time Frame: Transplant, 90 days or death ] [ Designated as safety issue: Yes ] Transplant, 90 days of support from date of discharge, 90 days of in-hospital support for subjects who are not discharged, or death |
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| Original Secondary Outcome Measures ICMJE |
Companion Driver can be safely used at home. [ Time Frame: Transplant, 180 days or death ] [ Designated as safety issue: Yes ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | SynCardia Freedom Driver System Study | ||||||||
| Official Title ICMJE | SynCardia Freedom Driver System Study | ||||||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label |
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| Condition ICMJE | Biventricular Failure | ||||||||
| Intervention ICMJE | Device: CardioWest temporary Total Artificial Heart (TAH-t) System
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. |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00733447 | ||||||||
| Other Study ID Numbers ICMJE | RA-142, P030011 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | SynCardia Systems. Inc. | ||||||||
| Study Sponsor ICMJE | SynCardia Systems. Inc. | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | SynCardia Systems. Inc. | ||||||||
| Verification Date | June 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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