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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ventilator Induced Diaphragm Dysfunction
• Intervention / Treatment: Device: Lungpacer Diaphragm Pacing Therapy

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Megan O'Toole; Phone Number: 484-350-4530; Email: motoole@lungpacer.com
• Study Contact Backup: Name: AERO-PAS Study; Email: aero-pas@lungpacer.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.
11. Known or suspected phrenic nerve paralysis.
12. Any electrical device (implanted or external) that may be prone to interaction with, or interference from the AeroPace System, including neurological pacing/stimulator devices, cardiac pacemakers and defibrillators.
13. Current hemodynamic instability
14. Uncontrolled sepsis or septic shock.
15. Current or untreated bacteremia.
16. Expecting withdrawal of life support and/or shift to palliation as the goal of care.
17. Known or suspected to be pregnant or lactating.
18. Currently being treated in another clinical trial studying an experimental treatment that could affect the study primary outcome.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lungpacer AeroPace Therapy; Subject receives AeroPace therapy consisting of 60 stimulations, twice daily for a total of 120 stimulations/day, plus standard of care for weaning from mechanical ventilation including at least once daily spontaneous breathing trials.	Device: Lungpacer Diaphragm Pacing Therapy; Transvenous phrenic nerve stimulation to induce diaphragm contraction.; Other Names: Lungpacer DPTS; AeroPace System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event Profile	All Serious Adverse Events from enrollment to study exit and device- and/or procedure-related Adverse Events until successful wean, withdrawal/death, transfer or day 30 (whichever comes first).	30 days
Successful Weaning	Proportion of subjects successfully weaned by Day 30	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Days on mechanical ventilation from time of initial placement procedure through Day 30.	30 days
Incidence of reintubation/reinstatement of MV through Day 30	30 days
Incidence of device/procedure related SAEs as compared to RESCUE 3 Treatment group subjects	30 days
Mortality through Day 30	30 days
Incidence of tracheostomy from enrollment through Day 30	30 days
ICU/hospital days from initial placement procedure to Day 32	32 days

Collaborators and Investigators

• Sponsor: Lungpacer Medical Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: VIDD; SBT; Weaning Failure; Diaphragm Atrophy; Phrenic Nerve Stimulation
• Other Study ID Numbers: P-1200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No