A Post Market Surveillance Study of the Hemovent Extracorporeal Cardiopulmonary Support System of Cardiac and Respiratory Support: The MOBYBOX Trial

Study Overview
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Brief Summary
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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.

Official Title
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A Post Market Surveillance Study of the Hemovent Extracorporeal Cardiopulmonary Support System for Cardiac and Respiratory Support: The MOBYBOX Trial

Conditions
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Cardiac Failure, Respiratory Failure, Cardio-Respiratory Failure

Intervention / Treatment
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* Device: MOBYBOX System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with cardiac, respiratory or cardiorespiratory failure and 1 of the 5 following sets of findings: A Murray score ≥ 3.0 and/or severe hypoxemia with A PaO2/FIO2 < 100 mm on > 0.9 FIO2; Uncompensated hypercapnia with pH <7.2 despite a Pplateau > 30 cm H20; Significant air leak/bronchopleural fistula; Need for intubation in a patient on lung transplant list; Immediate cardiac or respiratory collapse (pulmonary embolus, blocked airway, unresponsive to optimal care); Written consent of the patient or the legal guardian or external consulting physician as designated and approved by the Ethics Committee. Exclusion Criteria: High pressure ventilation (FIO2 > 0.9 and Pplateau > 30 cm H2O) or high FIO2 requirements for more than 7 days; Severe intracranial bleeding, which precludes the use of anticoagulation therapy or any other inability to be anticoagulated Excessive weight (> 180 Kg) Severe irreversible brain injury (e.g., hypoxic brain injury) Inability to accept blood products; Any condition or organ dysfunction that would limit the likelihood of overall benefit from ECMO, such as severe, irreversible brain injury, hepatic and/or renal failure, or untreatable metastatic cancer; Immunosuppression with an absolute neutrophil count < 400/mm3; Patient has been treated with ECMO ≤ 48 hours. For veno-veno ECMO in the setting of respiratory failure the following exclusion criteria apply: Severe pulmonary hypertension (mPAP > 50 mm Hg) Severe right or left sided heart failure (EF < 25%) For veno-arterial ECMO in the setting of cardiac insufficiency: Severe aortic regurgitation Aortic dissection. The patient is moribund, or the patient has severe or deteriorating damage in critical body systems. Patient is participating in an investigational drug or device study trial that has not reached the primary endpoint or that interferes with the current study endpoints. Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: MOBYBOX System|extracorporeal cardiopulmonary support|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates 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. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | 24 hours | 
| Mortality rate | All-cause mortality up to 30 days post-intervention | 30 days |