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A Post-Approval Multicenter Study to Assess the Continued Safety and Effectiveness of the AeroPace® System
Sponsor: Lungpacer Medical Inc.
Summary
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.
Official title: A Post-Approval Multicenter Study to Assess the Continued Safety and Effectiveness of the AeroPace® System - The AERO-PAS Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-07-01
Completion Date
2028-02-01
Last Updated
2026-03-17
Healthy Volunteers
No
Conditions
Interventions
Lungpacer Diaphragm Pacing Therapy
Transvenous phrenic nerve stimulation to induce diaphragm contraction.