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OpenTrials
Completed

NCT Number: NCT03969797

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

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.

Completed

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Key information

Conditions

Cardiac Arrest, Sudden Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radianqbio

Seoul, 08588, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • out-of-hospital cardiac arrest
  • > 12 months

Exclusion criteria

  • age under 12 months

Treatment and study plan

RADIAQBIO Heart Guardian HR-501

Device

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

Primary outcomes

  1. Identification ECG from patients

    Time frame: during operating, approximately 2 hours

    The AED identifies if ECG is VF or normal

Secondary outcomes

  1. Survival patients by electric shock

    Time frame: 24 hours

    Ratio of patients were survived after electric shock delivered

Sponsors and collaborators

Lead sponsor

RadianQbio

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
May 31, 2019
Registry last updated
May 31, 2019

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.

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