NCT03969797

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
Last Updated

May 31, 2019

Status Verified

May 1, 2019

Enrollment Period

2.5 years

First QC Date

May 27, 2019

Last Update Submit

May 29, 2019

Conditions

Cardiac Arrest, Sudden

Outcome Measures

Primary Outcomes (1)

  • Identification ECG from patients

    The AED identifies if ECG is VF or normal

    during operating, approximately 2 hours

Secondary Outcomes (1)

  • Survival patients by electric shock

    24 hours

Interventions

RADIAQBIO Heart Guardian HR-501DEVICE

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

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients using AED HR-501

You may qualify if:

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

You may not qualify if:

  • age under 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radianqbio

Seoul, 08588, South Korea

Location

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
32 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2019

First Posted

May 31, 2019

Study Start

March 25, 2016

Primary Completion

October 8, 2018

Study Completion

January 15, 2019

Last Updated

May 31, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)