AED 3 Post-Approval Study

NCT ID: NCT05013333

Last Updated: 2025-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-30

Study Completion Date

2029-02-28

Brief Summary

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

Detailed Description

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Conditions

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Cardiac Arrest, Out-Of-Hospital

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AED 3 with Uni-padz

Group Type OTHER

AED 3 with Uni-padz

Intervention Type DEVICE

Use of AED 3 with Uni-padz by lay rescuer

Interventions

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AED 3 with Uni-padz

Use of AED 3 with Uni-padz by lay rescuer

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zoll Medical Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University at Buffalo

Buffalo, New York, United States

Site Status

Colonie EMS

Latham, New York, United States

Site Status

Countries

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United States

Other Identifiers

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47701

Identifier Type: -

Identifier Source: org_study_id

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