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

NCT04183660 | Recruiting

• 1 other identifier: HVT-MB1
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Device performance success

  every 4 hours while the patient receives ECMO using the MOBYBOX device

• Adverse Event rate

  24 hours

• Mortality rate

  30 days

Interventions

MOBYBOX System DEVICE

extracorporeal cardiopulmonary support

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hemovent GmbH: lead
• seleon GmbH: collaborator

Study Sites (4)

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

RECRUITING

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, 45147, Germany

RECRUITING

Universitätsklinikum Halle

Halle, Saxony-Anhalt, 06120, Germany

RECRUITING

Helios Klinikum Erfurt

Erfurt, 99089, Germany

RECRUITING

MeSH Terms

Conditions

Heart Failure; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Tienush Rassaf, Prof.

  Uniklinikum Essen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yvonne Seibt

CONTACT

+49 174 1773839; yseibt@hemovent.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 3, 2019
• Study Start: April 30, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-04

Locations

DE (4)