The purpose of this observational study is to evaluate the performance of the Berlin Heart EXCOR Active driving unit while being used with the approved EXCOR ventricular assist device system.
The study has a prospective, multicenter, international, single arm, observational design. Study enrollment is expected to take 18 months and subjects will be followed until they reach an outcome or for 45 days on the EXCOR Active driving unit. The overall study duration is expected to be approximately 20 months.
Study Type
OBSERVATIONAL
Enrollment
24
No intervention due to observational design
Deutsches Herzzentrum Berlin
Berlin, Germany
EXCOR Active device performance
Time frame: 52 days
Successful patient outcome rates
Successful outcome is defined as: * survival to transplant, or * survival to recovery/successful weaning, or * survival on EXCOR Pediatric at 45 days post-switch to EXCOR Active.
Time frame: Whenever it happens or 52 days
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