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Not yet recruiting NCT07477054

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

No phase Interventional Ventilator Induced Diaphragm Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lungpacer Diaphragm Pacing Therapy.
Who it may be relevant to
Registry conditions: Ventilator Induced Diaphragm Dysfunction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Lungpacer Diaphragm Pacing Therapy
    Transvenous phrenic nerve stimulation to induce diaphragm contraction.

Primary outcome measures

  • Adverse Event Profile [Time frame: 30 days]
  • Successful Weaning [Time frame: 30 days]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07477054 · P-1200

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗