Not Yet RecruitingNot Applicable

A Post-Approval Multicenter Study to Assess the Continued Safety and Effectiveness of the AeroPace® System

120 participantsStarted 2026-07-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.
✕. Clinically overt congestive heart failure that is preventing weaning.
✕. Currently being treated with neuromuscular blockade that could affect phrenic nerve / diaphragm contraction.
✕. Pre-existing neurological, neuromuscular or muscular disorder that could affect the respiratory muscles.
✕. Pre-existing severe chronic pulmonary fibrosis.

What they're measuring

Adverse Event Profile

Timeframe: 30 days

Successful Weaning

Timeframe: 30 days

Trial details

NCT IDNCT07477054

SponsorLungpacer Medical Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-02-01

Contact for this trial

Megan O'Toole

484-350-4530 motoole@lungpacer.com

View on ClinicalTrials.gov More Ventilator Induced Diaphragm Dysfunction trials