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

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

NCT07477054•Lungpacer Medical Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Are 18 years or older, and,
•2. Will have been mechanically ventilated for ≥96 hours (4 days) by the time of Catheter insertion, and,
•3. Have not weaned from MV, and,
•4. Have failed an institutional SBT within 48 hours of enrollment.

Exclusion Criteria

•1. Invasive mechanical ventilation \>90 days.
•2. Currently on extracorporeal membrane oxygenation (ECMO).
•3. Weaning failure due to hypervolemia.
•4. Medical history (including imaging) or known anatomy that prevents percutaneous insertion of the Catheter into the intended thoracic vein on the left side.
•5. Clinically overt congestive heart failure that is preventing weaning.
•6. Currently being treated with neuromuscular blockade that could affect phrenic nerve / diaphragm contraction.
•7. Pre-existing neurological, neuromuscular or muscular disorder that could affect the respiratory muscles.
•8. Pre-existing severe chronic pulmonary fibrosis.
•9. Known pleural effusions occupying greater than one third of the pleural space on either side.
•10. BMI \>70 kg/m2.
+8 more criteria

Key Dates

Start Date

July 1, 2026

Primary Completion Date

February 1, 2028

Completion Date

February 1, 2028

Last Updated

March 17, 2026

Enrollment

120

ESTIMATED participants

Conditions

Ventilator Induced Diaphragm Dysfunction

Interventions

Lungpacer Diaphragm Pacing Therapy

DEVICE

Contacts

Megan O'Toole

CONTACT

484-350-4530 motoole@lungpacer.com

AERO-PAS Study

CONTACT

aero-pas@lungpacer.com

Randomized Study of the pdSTIM™ System in Failure to Wean Mechanically Ventilated Patients

NCT05998018

NeuromodulationPhrenic Nerve Stimulation+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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