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

ConditionVentilator Induced Diaphragm Dysfunction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLungpacer Medical Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Lungpacer Diaphragm Pacing Therapy

    Device

    Transvenous phrenic nerve stimulation to induce diaphragm contraction.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Lungpacer AeroPace TherapyOther 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
30 days
2

Successful Weaning

Proportion of subjects successfully weaned by Day 30

Time frame
30 days

Secondary outcomes

1

Days on mechanical ventilation from time of initial placement procedure through Day 30.

Time frame
30 days
2

Incidence of reintubation/reinstatement of MV through Day 30

Time frame
30 days
3

Incidence of device/procedure related SAEs as compared to RESCUE 3 Treatment group subjects

Time frame
30 days
4

Mortality through Day 30

Time frame
30 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lungpacer Medical Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: