Status:
UNKNOWN
SynCardia Companion 2 Driver System Post Approval Study Protocol With INTERMACS™-Based Data Collection
Lead Sponsor:
SynCardia Systems. LLC
Conditions:
Bi-ventricular Failure
Eligibility:
All Genders
Brief Summary
Study Purpose The purpose of this PAS is to confirm that patients implanted with the temporary Total Artificial Heart (TAH-t) and supported with the Companion 2 Driver System have outcomes similar to...
Eligibility Criteria
Inclusion
- Implanted with the TAH-t
- Patient or their legal representative has signed an informed consent (ICF) form for INTERMACS Registry participation or waiver of consent has been approved at the implanting institution.
Exclusion
- Patient or legal guardian has not signed an ICF for INTERMACS Registry participation, if required at the institution.
- Patient is incarcerated.
Key Trial Info
Start Date :
December 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT01919320
Start Date
December 1 2013
End Date
July 1 2023
Last Update
October 23 2020
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.