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

Cardiac Arrest, Sudden Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03969797
• Other study ID #: HR501_20190527
• Status: Completed
• Start date: March 25, 2016
• Est. completion date: January 15, 2019

Study information

• Verified date: May 2019
• Source: RadianQbio
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 15, 2019
• Est. primary completion date: October 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

• out-of-hospital cardiac arrest

• > 12 months

Exclusion Criteria:

• age under 12 months

Related Conditions & MeSH terms

• Cardiac Arrest, Sudden
• Death, Sudden, Cardiac
• Heart Arrest

Intervention

Device:
• RADIAQBIO Heart Guardian HR-501
Arm one offers ECG data and electric shocks recorded during AED operation.

Locations

Country	Name	City	State
Korea, Republic of	Radianqbio	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
RadianQbio

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification ECG from patients	The AED identifies if ECG is VF or normal	during operating, approximately 2 hours
Secondary	Survival patients by electric shock	Ratio of patients were survived after electric shock delivered	24 hours