Back to resultsSynCardia Freedom Driver System Study
Primary Purpose
Biventricular Failure
Status
Approved for marketing
Phase
Locations
United States
Study Type
Expanded Access
Intervention
CardioWest temporary Total Artificial Heart (TAH-t) System
Sponsored by
About this trial
This is an expanded access trial for Biventricular Failure focused on measuring Biventricular failure
Eligibility Criteria
Inclusion Criteria:
- Patients who are implanted with the TAH-t and are clinically stable.
Exclusion Criteria:
- Patients who are implanted with the TAH-t and are not clinically stable.
Sites / Locations
- Mayo Clinic Hospital
- Hospital of the University of Pennsylvania
- Virginia Commonwealth University Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00733447
Brief Title
SynCardia Freedom Driver System Study
Official Title
SynCardia Freedom Driver System Study
Study Type
Expanded Access
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Approved for marketing
Study Start Date
March 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
May 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SynCardia Systems. LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biventricular Failure
Keywords
Biventricular failure
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
CardioWest temporary Total Artificial Heart (TAH-t) System
Intervention Description
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.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who are implanted with the TAH-t and are clinically stable.
Exclusion Criteria:
Patients who are implanted with the TAH-t and are not clinically stable.
Facility Information:
Facility Name
Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Virginia Commonwealth University Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
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SynCardia Freedom Driver System Study
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