The purpose of this study is to evaluate prospectively the safety and performance of the MOBYBOX System in the veno-arterial configuration in patients with cardiorespiratory failure or in the veno-venous configuration in patients with severe respiratory failure.
Study Type
OBSERVATIONAL
Enrollment
60
extracorporeal cardiopulmonary support
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
RECRUITINGUniversitätsklinikum Essen
Essen, North Rhine-Westphalia, Germany
RECRUITINGUniversitätsklinikum Halle
Halle, Saxony-Anhalt, Germany
RECRUITINGRates of device and procedure related serious adverse events
Acute safety defined as rates of device and procedure related serious adverse events up to 24 hours post-intervention.
Time frame: 24 hours
Device performance success
Device performance success (defined as the ability to establish either veno-arterial ECMO to support cardiorespiratory function and tissue oxygenation or veno-venous ECMO to support respiratory function and tissue oxygenation)
Time frame: every 4 hours while the patient receives ECMO using the MOBYBOX device
Adverse Event rate
Acute safety defined as rates adverse events up to 24 hours post-intervention.
Time frame: 24 hours
Mortality rate
All-cause mortality up to 30 days post-intervention
Time frame: 30 days
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Helios Klinikum Erfurt
Erfurt, Germany
RECRUITING