The purpose of this study is to collect prospective safety and performance information for the i-COR® device using synchronized cardiac assist in the setting of combined heart-lung failure or in high risk percutaneous intervention procedures in catheterization lab.
Study Type
OBSERVATIONAL
Enrollment
47
The i-cor Synchronized Cardiac Assist Device delivers pulsatile cardiac assist synchronized to the ECG during diastole and provides enhanced oxygenation through a membrane oxygenator.
Kerckhoff Klinik
Bad Nauheim, Hesse, Germany
Number of Participants With Device and Procedure Related Serious Adverse Events
Acute safety defined as rates of device and procedure related serious adverse events up to 30 days post-intervention.
Time frame: 30 days
Number of Participants Treated With Technical Success of the Device
Technical success (defined as the ability to successfully deliver the i-COR® SYNCHRONIZED CARDIAC ASSIST device without serious adverse events).
Time frame: 24 hours
Number of Participants With Device Performance Success
Device performance success (defined as the ability to establish synchronized pulsatile cardiac assist, enhance cardiac function and improve tissue oxygenation) assessed immediately post-procedure (acute) and serially as the device remains in place and provides cardiac support over time in each patient.
Time frame: 7 days
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