A Post-Approval Multicenter Study to Assess the Continued Safety and Effectiveness of the AeroPace® System
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLungpacer Medical Inc.
About this trial
A single-arm, prospective, multicenter cohort study to assess the 30-day continued safety and effectiveness of the AeroPace System in patients on mechanical ventilation (MV) at least 96 hours and who have not weaned. This is a study collecting real-world data in a post-market setting.
Eligibility criteria
Qualifiers
Are 18 years or older, and,
Will have been mechanically ventilated for ≥96 hours (4 days) by the time of Catheter insertion, and,
Have not weaned from MV, and,
Have failed an institutional SBT within 48 hours of enrollment.
Disqualifiers
Invasive mechanical ventilation >90 days.
Currently on extracorporeal membrane oxygenation (ECMO).
Weaning failure due to hypervolemia.
Medical history (including imaging) or known anatomy that prevents percutaneous insertion of the Catheter into the intended thoracic vein on the left side.
Trial design
Treatments tested in this trial
- Lungpacer Diaphragm Pacing Therapy
Treatment groups
120 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov