Cardiac FailureNCT04183660
A Post Market Surveillance Study of the Hemovent Extracorporeal Cardiopulmonary Support System:The MOBYBOX Trial
An observational study of Cardiac Failure and Respiratory Failure, run by Hemovent GmbH at 4 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Failure, Respiratory Failure, Cardio-Respiratory Failure
- What is being tested?
- MOBYBOX System
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 4 sitesGermany
- Study dates
- 30 Apr 2024to Dec 2026
- How long will I take part?
- 30 Days
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consented patients with cardiorespiratory failure or ith severe respiratory failure who meet all of the inclusion and none of the exclusion criteria and in whom the investigator intends to treat the patient with cardiopulmonary support using the Hemovent MOBYBOX System.
Who may be able to join
- Diagnosed with cardiac, respiratory or cardiorespiratory failure or imminent 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/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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany4 sites, 4 recruiting
- Recruiting
Helios Klinikum Erfurt
Erfurt, 99089
Heinrich Groesdonk, Professor, heinrich.groesdonk@helios-gesundheit.de
Magdalena Römmer, Doctor, +49 361 781-6075, magdalena.roemmer@helios-gesundheit.de
- Recruiting
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, 45147
Tienush Rassaf, Prof., +49 201 723-4801, tienush.rassaf@uk-essen.de
Amir Abbas Mahabadi, Prof., +49 201 723-84822, amir-abbas.mahabadi@uk-essen.de
- Recruiting
Universitätsklinikum Halle
Halle, Saxony-Anhalt, 06120
Alexander Vogt, MD, +49 3455572601, alexander.vogt@uk-halle.de
Alexander Vogt, MD
- Recruiting
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Christian Kühn, Professor, +49 511 532-0, Kuehn.Christian@mh-hannover.de
Heiko Schenk, MD
About this study
Official title: A Post Market Surveillance Study of the Hemovent Extracorporeal Cardiopulmonary Support System for Cardiac and Respiratory Support: The MOBYBOX Trial
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.
- Conditions
- Cardiac Failure, Respiratory Failure, Cardio-Respiratory Failure, Imminent Cardiorespiratory or Respiratory Failure
- Being tested
- MOBYBOX System
- Medical subject headings
- Heart Failure, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOBYBOX SystemDevice
extracorporeal cardiopulmonary support
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (3)
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)
Measured: 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.
Measured: 24 hours
Mortality rate
All-cause mortality up to 30 days post-intervention
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start30 Apr 2024
- Primary completionApr 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Hemovent GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- seleon GmbH
- Responsible party
- Sponsor
- Investigators
- Tienush Rassaf, Prof., Principal investigator, Uniklinikum Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183660
- Sponsor's protocol ID
- HVT-MB1
- Status last verified
- Apr 2025
- First submitted
- 27 Nov 2019
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No