Study of TransAeris® System for Enhanced Recovery After Surgery in France

NCT05404477 | Completed FDA Device

• 1 other identifier: CLIN 20-1000-108
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted as a randomized trial of the TransAeris system for the prevention and treatment of ventilator-induced diaphragm dysfunction (VIDD) in patients identified prior to surgery to be at greater risk of prolonged mechanical ventilation (PMV).

Conditions

Ventilator-Induced Diaphragm Dysfunction

Outcome Measures

Primary Outcomes (2)

• Serious device-related adverse events

  Number of serious device-related adverse effects

  60 days after implantation

• Time on mechanical ventilation

  Time measured in hours on Mechanical Ventilation and Proportion of patients weaned at 48- and 120-hours post-op

  90 days after study completion

Secondary Outcomes (7)

• ICU Care

  90 days after study completion

• Device related adverse events

  90 days after study completion

• Mortality

  90 days after study completion

• Mechanical ventilation time

  90 days after study completion

• EMG

  90 days after study completion

Study Arms (2)

Treatment

OTHER

Treatment with TransAeris stimulation upon completion of procedure

Device: TransAeris System

Control

OTHER

Control subject will cross-over to treatment with the TransAeris System if still on mechanical ventilation at 120 hours post-op

Device: TransAeris System

Interventions

TransAeris System DEVICE

The TransAeris System includes four TransLoc® intramuscular diaphragm electrodes, the TransAeris external stimulator, and the FrictionLoc® connectors which provide the interface between the TransLoc electrodes and the TransAeris stimulator.

Control; Treatment

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is undergoing an open cardiac procedure by median sternotomy
• Subject is at risk of prolonged mechanical ventilation according to one or more of the following criteria:
• Prior open cardiac surgery
• Left Ventricular Ejection Fraction (LVEF) ≤ 30%
• History of TIA or CVA
• Pre-operative or anticipated intraoperative intra-aortic balloon pump
• History of COPD
• Subject is at least 22 years of age
• Informed consent has been obtained from the subject
• Subject is covered by a healthcare insurance

You may not qualify if:

• Subject is on invasive mechanical ventilation prior to procedure
• Subject has known or pre-existing phrenic nerve paralysis
• Subject is having a left ventricular assist device (LVAD) implanted
• Subject has progressive, non-reversible neuromuscular disease affecting the diaphragm
• Subject is pregnant or lactating
• Subject is actively participating in another clinical study which could affect outcomes in this study
• Subject deprived of liberty
• Subject under court protection

Sponsors & Collaborators

• Synapse Biomedical: lead

Study Sites (1)

CHU - Nantes

Nantes, France

Location

Related Publications (1)

• David CH, Vourc'h M, Guimbretiere G, Mugniot A, Lacoste P, Cadiet J, Rozec B, Arora R, Pelletier M, Sabik J, Onders R. Multicentre Study of Diaphragm Pacing in High-Risk Cardiac Surgery to Decrease Postoperative Mechanical Ventilation. Eur J Cardiothorac Surg. 2026 Jan 6;68(1):ezaf472. doi: 10.1093/ejcts/ezaf472.

  PMID: 41416899 DERIVED

Study Officials

• Charles-Henri David

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is an open label, randomized, cross-over study in adult open cardiac surgery patients. All subjects will receive TransLoc electrodes at the time of open sternotomy cardiac procedure. Half of subjects will have TransAeris turned on upon entry to ICU, the other half will receive standard of care with TransAeris turned on if still intubated on mechanical ventilation after 120 hours.

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: June 3, 2022
• Study Start: June 22, 2022
• Primary Completion: July 13, 2023
• Study Completion: August 17, 2023
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)