The purpose of the study is to monitor the clinical safety and performance of the EXCOR Venous Cannula in context of an EXCOR VAD therapy to ensure continued acceptability of identified risks, to enable detecting emerging risks and to assess clinical improvement on both short- and long-term.
Patient or his/her parent/guardian or legally authorized representative has given the consent by means of a written, signed and dated informed consent form,
The indications on RVAD and BVAD use of the EXCOR VAD apply,
Patient shall be on transplant list or at least eligible for HTx,
BSA (body surface area) greater than or equal to 1.2 m².
Patient or his/her parents/legal guardian or legally authorized guardian has not given the consent,
The contraindications of EXCOR VAD apply.
Twenty patients with failing/absence of the right heart. The indications on RVAD and BVAD use of the EXCOR VAD apply.
Cohort
Prospective
No intervention
Other interventionNo intervention due to observational design
Rate of mortality
Short-term mortality
Rate of major bleeding
Short-term rate of major bleeding
Rate of thrombosis
Short-term rate of thrombosis
Survival to heart transplantation
Long-term survival to heart transplantation
Rate of adverse events
Safety of the device
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