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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Germany
Helios Klinikum Erfurt
RECRUITING
Erfurt
Universitätsklinikum Essen
RECRUITING
Essen
Universitätsklinikum Halle
RECRUITING
Halle
Medizinische Hochschule Hannover
RECRUITING
Hanover
Contact Information
Primary
Yvonne Seibt
yseibt@hemovent.com
+49 174 1773839
Time Frame
Start Date: 2024-04-30
Estimated Completion Date: 2026-12
Participants
Target number of participants: 60
Authors
Phillipp Lepper
Related Therapeutic Areas
Sponsors
Leads: Hemovent GmbH
Collaborators: seleon GmbH

This content was sourced from clinicaltrials.gov