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

Quality Feedback of 19 Cases by AED Operation in Out-of-hospital Environment: a Prospective Randomized Log Analysis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03969797

Enrollment

Registered

2019-05-31

Start date

2016-03-25

Completion date

2019-01-15

Last updated

2019-05-31

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

Conditions

Cardiac Arrest, Sudden

Brief summary

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

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.

Interventions

DEVICERADIAQBIO Heart Guardian HR-501

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* age under 12 months

Design outcomes

Primary

Measure	Time frame	Description
Identification ECG from patients	during operating, approximately 2 hours	The AED identifies if ECG is VF or normal

Secondary

Measure	Time frame	Description
Survival patients by electric shock	24 hours	Ratio of patients were survived after electric shock delivered

Countries

South Korea

Outcome results

None listed

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