AED 3 Post-Approval Study

Post-Approval Study for AED 3 With Uni-padz

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05013333

Enrollment

Registered

2021-08-19

Start date

2021-03-30

Completion date

2029-02-28

Last updated

2025-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest, Out-Of-Hospital

Brief summary

Demonstrate appropriate CPR sensor placement on pediatric and adult patients and demonstrate delivery of appropriate energy level of shocks to pediatric and adult patients.

Interventions

DEVICEAED 3 with Uni-padz

Use of AED 3 with Uni-padz by lay rescuer

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Suspected out-of-hospital cardiac arrest * Use of ZOLL AED 3 public-access defibrillator (running software v.1.03.602 or newer (US) or v. 6.03.006 or newer(OUS)) with Uni-padz III * Unconsciousness * Absence of breathing * Absence of pulse and other signs of circulation

Exclusion criteria

* Pre-existing Do Not Attempt Resuscitation (DNAR) orders * No evidence of cardiac arrest

Design outcomes

Primary

Measure	Time frame	Description
CPR sensor placement	Procedure (At time of device placement)	Rate of appropriate placement of the CPR electrodes and compression sensor
Selection of adult or pediatric mode	Procedure (At time of device placement)	Rate of appropriate selection of child mode by pressing Child Mode button or adult mode by not pressing Child Mode button determined by energy level of first shock

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026