Recruiting

Safety study of a heart-lung support machine for failing hearts and lungs

Plain-English translation of NCT04183660 on ClinicalTrials.gov ↗ · Source last updated May 2025 · Translation generated June 2026 · How we translate trials

What is this trial?

This trial is testing the MOBYBOX System, a machine that temporarily takes over the work of your heart and lungs when they are too weak to function on their own. The machine pumps and oxygenates your blood outside your body, giving your organs time to recover or giving you time to reach a transplant. Researchers want to make sure the MOBYBOX System is safe and works well in real-world use.

Patients with severe heart and lung failure can die quickly without urgent support. This treatment helps keep patients alive during a medical crisis, but doctors need to understand how well it works and what safety concerns emerge when it's used in everyday hospital care.

Do you qualify?

You likely qualify if…

you have been diagnosed with heart failure, lung failure, or both (or are at immediate risk of collapse)
you have severe low oxygen levels in your blood despite maximum breathing support, or severely high carbon dioxide levels despite ventilator support
you have a large air leak in your lungs, need a breathing tube before a lung transplant, or are at immediate risk of cardiac or respiratory collapse
you are able to receive blood products and be treated with blood thinners
you or your legal guardian or physician representative can provide informed written consent

You likely don't qualify if…

you have been on a heart-lung support machine in the past 48 hours
you require extremely high oxygen levels (over 90% oxygen) and high breathing pressure for more than 7 days
you have severe bleeding in the brain that would prevent you from safely receiving blood thinners
you have severe permanent brain damage or other conditions that would make this treatment unlikely to help you
you weigh more than 180 kilograms (about 400 pounds)

What participation looks like

If you qualify, doctors will place you on the MOBYBOX System in the hospital—either using a vein-to-artery connection if your heart is failing, or a vein-to-vein connection if your lungs are failing. The research team will closely monitor your safety and how well the machine supports your organs while you recover or await a transplant. You'll remain hospitalized during treatment, and researchers will track your health outcomes and any side effects throughout your care.

AI-generated summary from trial data · Jun 13, 2026 · Not medical advice

Trial locations(4 sites)

Germany

Medizinische Hochschule Hannover, Hanover, Lower Saxony

Universitätsklinikum Essen, Essen, North Rhine-Westphalia

Universitätsklinikum Halle, Halle, Saxony-Anhalt

Helios Klinikum Erfurt, Erfurt