AED Log Analysis of 19 Cases in Out-of-hospital Environment

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

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-25

Study Completion Date

2019-01-15

Brief Summary

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The study performed to demonstrate a reasonable assurance of safety and effectiveness of the Heart Guardian HR-501 when used in an out-of-hospital environment.

Detailed Description

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The defibrillation study was conducted by analyzing the logs of Heart Guardian HR-501 with Radian ECG Viewer. The product analysis was studied whether the device was operated normally in ECG analysis and electric shocks.

Conditions

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Cardiac Arrest, Sudden

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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RADIAQBIO Heart Guardian HR-501

Arm one offers ECG data and electric shocks recorded during AED operation.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* out-of-hospital cardiac arrest
* \> 12 months

Exclusion Criteria

* age under 12 months

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Radianqbio

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HR501_20190527

Identifier Type: -

Identifier Source: org_study_id