Ventilator Induced Diaphragm DysfunctionAERO-PASNCT07477054
A Post-Approval Multicenter Study to Assess the Continued Safety and Effectiveness of the AeroPace® System
A study testing Lungpacer Diaphragm Pacing Therapy in people with Ventilator Induced Diaphragm Dysfunction, run by Lungpacer Medical Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Induced Diaphragm Dysfunction
- What is being tested?
- Lungpacer Diaphragm Pacing Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2026to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Pre-existing neurological, neuromuscular or muscular disorder that could affect the respiratory muscles.
- Pre-existing severe chronic pulmonary fibrosis.
- Known pleural effusions occupying greater than one third of the pleural space on either side.
- BMI >70 kg/m2.
- Known or suspected phrenic nerve paralysis.
- 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.
- Current hemodynamic instability
- Uncontrolled sepsis or septic shock.
- Current or untreated bacteremia.
- Expecting withdrawal of life support and/or shift to palliation as the goal of care.
- Known or suspected to be pregnant or lactating.
- Currently being treated in another clinical trial studying an experimental treatment that could affect the study primary outcome.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
AERO-PAS Study contact
About this study
Official title: 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.
- Conditions
- Ventilator Induced Diaphragm Dysfunction
- Being tested
- Lungpacer Diaphragm Pacing Therapy
- Keywords
- VIDD, Diaphragm Atrophy, Weaning Failure, SBT, Phrenic Nerve Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lungpacer Diaphragm Pacing TherapyDevice
Also called Lungpacer DPTS, AeroPace System
Transvenous phrenic nerve stimulation to induce diaphragm contraction.
| Study group | Role | What they receive |
|---|---|---|
| Lungpacer AeroPace Therapy | Other | 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. Receives: Device: Lungpacer Diaphragm Pacing Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 days
Successful Weaning
Proportion of subjects successfully weaned by Day 30
Measured: 30 days
Secondary outcomes (6)
Days on mechanical ventilation from time of initial placement procedure through Day 30.
Measured: 30 days
Incidence of reintubation/reinstatement of MV through Day 30
Measured: 30 days
Incidence of device/procedure related SAEs as compared to RESCUE 3 Treatment group subjects
Measured: 30 days
Mortality through Day 30
Measured: 30 days
Incidence of tracheostomy from enrollment through Day 30
Measured: 30 days
ICU/hospital days from initial placement procedure to Day 32
Measured: 32 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start31 Oct 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Induced Diaphragm DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lungpacer Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477054
- Sponsor's protocol ID
- P-1200
- Acronym
- AERO-PAS
- Status last verified
- Aug 2026
- First submitted
- 12 Mar 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Approval Multicenter Study to Assess the Continued Safety and Effectiveness of the AeroPace® System - The AERO-PAS Study
- ClinicalTrials.gov ID
- NCT07477054
- Acronym / sponsor ID
- AERO-PAS / P-1200
- Conditions
- Ventilator Induced Diaphragm Dysfunction
- Keywords
- VIDD, Diaphragm Atrophy, Weaning Failure, SBT, Phrenic Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Lungpacer Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lungpacer AeroPace Therapy | Other | Device: Lungpacer Diaphragm Pacing TherapySubject 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lungpacer Diaphragm Pacing TherapyAlso: Lungpacer DPTS, AeroPace SystemTransvenous phrenic nerve stimulation to induce diaphragm contraction. | Device | Lungpacer AeroPace Therapy |
Primary outcome
Adverse Event Profile
Time frame: 30 days
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).
Successful Weaning
Time frame: 30 days
Proportion of subjects successfully weaned by Day 30
6 secondary outcomes
Days on mechanical ventilation from time of initial placement procedure through Day 30.
Time frame: 30 days
Incidence of reintubation/reinstatement of MV through Day 30
Time frame: 30 days
Incidence of device/procedure related SAEs as compared to RESCUE 3 Treatment group subjects
Time frame: 30 days
Mortality through Day 30
Time frame: 30 days
Incidence of tracheostomy from enrollment through Day 30
Time frame: 30 days
ICU/hospital days from initial placement procedure to Day 32
Time frame: 32 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: Yes
Related trials for Ventilator Induced Diaphragm Dysfunction
Recruiting
Shenfu Injection for the Prevention and Treatment of Ventilator Dependence in Mechanically Ventilated Patients
Ventilator-induced Diaphragm Dysfunction, Ventilator Dependence
Recruiting
Evaluation of heepSync, a Novel Algorithm for Transcutaneous Electrical Stimulation of Respiratory Muscles in Mechanically Ventilated Patients.
Ventilator-induced Diaphragm Dysfunction, VIDD
Enrolling by invitation
Standardization of IMT Dosage (UTIT) in Mechanical Ventilation.
Ventilator Induced Diaphragm Dysfunction, Respiratory Muscle Weakness
Recruiting
How Early Mobilization Impacts on Diaphragm Thickness in Critically Ill Children
Mechanical Ventilation Complication, Ventilator-induced Diaphragm Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AERO-PAS Study contact
Questions about this trial
What is this clinical trial studying?
A study testing Lungpacer Diaphragm Pacing Therapy in people with Ventilator Induced Diaphragm Dysfunction, run by Lungpacer Medical Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Cotts ((612) 986-7172, mcotts@lungpacer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event Profile (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026; AzTrials last refreshed its copy on 28 Oct 2026.