New pacemaker for the diaphragm aims to free patients from ventilators faster
NCT ID NCT07477054
First seen Jun 24, 2026 · Last updated Aug 07, 2026 · Updated 4 times
Summary
This study tests a device called AeroPace that electrically stimulates the nerve controlling the diaphragm, the main breathing muscle. It is for adults who have been on a mechanical ventilator for at least 4 days and are having trouble weaning off. The goal is to see if the device is safe and helps patients breathe on their own within 30 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AeroPace System (device that electrically stimulates the phrenic nerve to contract the diaphragm)
- What this could lead to
- If successful, this device could help people on breathing machines wean off ventilation faster and reduce complications from diaphragm weakness.
- What could go wrong
- This is a post-approval study collecting real-world data, not a randomized trial, so results may not prove the device is better than standard care. Risks include device-related serious adverse events.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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