Evaluating the safety and performance of the MOBYBOX System for heart and lung support

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

This study is testing how safe and effective the MOBYBOX system is for helping patients with heart and lung failure.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Hemovent GmbH (Industry-sponsored)
• Locations: 4 sites (Hanover, Lower Saxony and 3 other locations)
• Trial ID: NCT04183660 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the safety and effectiveness of the MOBYBOX Extracorporeal Cardiopulmonary Support System in patients experiencing cardiac, respiratory, or cardiorespiratory failure. The study will evaluate the device's performance in both veno-arterial and veno-venous configurations, depending on the patient's specific condition. Patients will be monitored for safety outcomes and device performance metrics, providing valuable data on its use in critical care settings.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with severe cardiac or respiratory failure who meet specific clinical criteria.

Not a fit: Patients with severe intracranial bleeding or those who cannot be anticoagulated may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance treatment options for patients suffering from severe heart and lung failure.

How similar studies have performed: While this approach is being evaluated in this specific context, similar extracorporeal support systems have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

* Diagnosed with cardiac, respiratory or cardiorespiratory failure or imminent 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/risk of cardiac or respiratory collapse (pulmonary embolus, blocked airway, blocked blood flow, 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.

Where this trial is running

Hanover, Lower Saxony and 3 other locations

• Medizinische Hochschule Hannover — Hanover, Lower Saxony, Germany (Recruiting)
• Universitätsklinikum Essen — Essen, North Rhine-Westphalia, Germany (Recruiting)
• Universitätsklinikum Halle — Halle, Saxony-Anhalt, Germany (Recruiting)
• Helios Klinikum Erfurt — Erfurt, Germany (Recruiting)

Study contacts

• Principal investigator: Tienush Rassaf, Prof. — Uniklinikum Essen
• Study coordinator: Yvonne Seibt

Conditions Cardiac Failure; Respiratory Failure; Cardio-Respiratory Failure; Imminent Cardiorespiratory or Respiratory Failure