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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04183660
• Other study ID #: HVT-MB1
• Status: Active, not recruiting
• Start date: July 22, 2020
• Est. completion date: February 2023

Study information

• Verified date: August 2021
• Source: Hemovent GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: February 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosed with cardiac, respiratory or cardiorespiratory failure and 1 of the 5

following sets of findings:

1. A Murray score = 3.0 and/or severe hypoxemia with A PaO2/FIO2 < 100 mm on > 0.9 FIO2;

2. Uncompensated hypercapnia with pH <7.2 despite a Pplateau > 30 cm H20;

3. Significant air leak/bronchopleural fistula;

4. Need for intubation in a patient on lung transplant list;

5. 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.

Related Conditions & MeSH terms

• Cardiac Failure
• Cardio-Respiratory Failure
• Heart Failure
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• MOBYBOX System
extracorporeal cardiopulmonary support

Locations

Country	Name	City	State
Germany	Universitätsklinikum des Saarlandes	Homburg Saar	Saarland

Sponsors (2)

Lead Sponsor	Collaborator
Hemovent GmbH	MAXIS Medical, LLC

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Adverse Event rate	Acute safety defined as rates adverse events up to 24 hours post-intervention.	24 hours
Secondary	Mortality rate	All-cause mortality up to 30 days post-intervention	30 days