NCT07477054

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Jul 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Jul 2026Feb 2028

First Submitted

Initial submission to the registry

March 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

July 7, 2026

Status Verified

July 1, 2026

Enrollment Period

1.6 years

First QC Date

March 12, 2026

Last Update Submit

July 2, 2026

Conditions

Ventilator Induced Diaphragm Dysfunction

Keywords

VIDDDiaphragm AtrophyWeaning FailureSBTPhrenic Nerve Stimulation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

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.

Device: Lungpacer Diaphragm Pacing Therapy

Interventions

Lungpacer Diaphragm Pacing TherapyDEVICE

Transvenous phrenic nerve stimulation to induce diaphragm contraction.

Also known as: Lungpacer DPTS, AeroPace System
Lungpacer AeroPace Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Megan Cotts

CONTACT

(612) 986-7172mcotts@lungpacer.com

AERO-PAS Study

CONTACT

aero-pas@lungpacer.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2026

First Posted

March 17, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

July 7, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share