AED Log Analysis of 19 Cases in Out-of-hospital Environment | NCT03969797

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

NCT03969797

Sponsor

RadianQbio

Status

Completed

Last Update Posted

May 31, 2019Actual

Enrollment

19Actual

Phase

Not provided

Conditions

Cardiac Arrest, Sudden

Interventions

RADIAQBIO Heart Guardian HR-501

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 25, 2016Actual

Primary Completion Date

Oct 8, 2018Actual

Completion Date

Jan 15, 2019Actual

First Submitted Date

May 27, 2019

First Submission Date that Met QC Criteria

May 29, 2019

First Posted Date

May 31, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2019

Last Update Posted Date

May 31, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

32 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RADIAQBIO Heart Guardian HR-501	Device	Arm one offers ECG data and electric shocks recorded during AED operation.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

out-of-hospital cardiac arrest
> 12 months

Exclusion Criteria:

age under 12 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients using AED HR-501

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Radianqbio		Seoul		08588	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016757	Death, Sudden, Cardiac

Ancestor Terms

ID	Term
D006323	Heart Arrest
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D003645	Death, Sudden

Browse Leaves

Not provided

Browse Branches

Not provided