AED 3 Post-Approval Study

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiac Arrest, Out-Of-Hospital Cardiovascular Diseases Heart Arrest Heart Diseases Out-of-Hospital Cardiac Arrest

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University at Buffalo, Buffalo, New York, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AED 3 with Uni-padz

Device

Use of AED 3 with Uni-padz by lay rescuer

Primary outcomes

CPR sensor placement

Time frame: Procedure (At time of device placement)

Rate of appropriate placement of the CPR electrodes and compression sensor
Selection of adult or pediatric mode

Time frame: 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

Sponsors and collaborators

Lead sponsor

Zoll Medical Corporation

Industry

Registry information

Official study title

Post-Approval Study for AED 3 With Uni-padz

Important dates

Study start: 2021
Primary completion: 2029
Study completion: 2029
First posted: Aug 19, 2021
Registry last updated: Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting