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.
The registry study has an observational, prospective, international, multi-center, non-randomized design. The registry is planned for 42 months (3.5 years), with an enrollment period of 28 months, the follow-up of up to 12 months.
Study Type
OBSERVATIONAL
Enrollment
20
No intervention due to observational design
LMU Klinikum
Munich, Germany
RECRUITINGRate of mortality
Short-term mortality
Time frame: 30 days
Rate of major bleeding
Short-term rate of major bleeding
Time frame: 30 days
Rate of thrombosis
Short-term rate of thrombosis
Time frame: 30 days
Survival to heart transplantation
Long-term survival to heart transplantation
Time frame: up to 12 months
Rate of adverse events
Safety of the device
Time frame: up to 12 months
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