Post-Approval Studies (PAS) Database

The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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AeroPace Post-Approval Study

General
Study Status	Study Pending
Application Number / Requirement Number	P240012 / PAS001
Date Original Protocol Accepted	01/30/2025
Date Current Protocol Accepted	01/30/2025
Study Name	AeroPace Post-Approval Study
Device Name	AeroPace® System
Clinical Trial Number(s)	NCT03783884
General Study Protocol Parameters
Study Design	Prospective Cohort Study
Data Source	New Data Collection
Comparison Group	Historical Control
Analysis Type	Descriptive
Study Population	Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives	A single-arm, prospective, multicenter cohort study to assess the 30-day 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 to evaluate the safety and effectiveness of the AeroPace System in the post-market setting. Safety and effectiveness outcomes will be compared to data from historical RESCUE 3 Control group subjects.
Study Population	Patients 18 years or older on mechanical ventilation at least 96 hours and who have not weaned.
Sample Size	Number of subjects: Up to 120 enrolled subjects in order to yield 100 subjects who have been treated with the AeroPace System. Number of sites: Up to 20 centers Sites location: United States
Key Study Endpoints	Safety Endpoints Primary: Incidence of SAEs including but not limited to vascular, infection and cardiac events. Secondary: • Incidence of device/procedure related SAEs (compared to RESCUE 3 Treatment group) • Mortality through Day 30 Effectiveness Endpoints Primary: Proportion of subjects successfully weaned by Day 30. Secondary: - Days on MV from time of initial placement procedure through Day 30 - Incidence of reintubation/reinstatement of MV through Day 30 - Incidence of tracheostomy from enrollment through Day 30 - ICU/hospital days from initial placement procedure to Day 32
Follow-up Visits and Length of Follow-up	Maximum study duration for any subject is 32 days. Follow-up will be through: - Withdrawal or death - Unsuccessful placement of the AeroPace Catheter – 48 hours after initial placement attempt - Successful wean/Unsuccessful wean/Transfer – to Day 32 Successfully weaned is defined as passing an SBT, or removed from MV, and not returned to MV within 48 hours.

AeroPace Post-Approval Study Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
6 month report	06/04/2025	05/30/2025	On Time
1 year report	12/04/2025
2 year report	12/04/2026
3 year report	12/04/2027
final report	06/01/2028

Contact Us

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Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background