Cardiac Arrest, SuddenNCT03969797
AED Log Analysis of 19 Cases in Out-of-hospital Environment
An observational study of Cardiac Arrest, Sudden, run by RadianQbio at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Cardiac Arrest, Sudden
- What is being tested?
- RADIAQBIO Heart Guardian HR-501
- Type of treatment
- Medical device
- How many people
- 19 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Mar 2016to 15 Jan 2019
- How long will I take part?
- 32 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients using AED HR-501
Who may be able to join
- out-of-hospital cardiac arrest
- > 12 months
Who cannot join
- age under 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality Feedback of 19 Cases by AED Operation in Out-of-hospital Environment: a Prospective Randomized Log Analysis
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.
Read the 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.
- Conditions
- Cardiac Arrest, Sudden
- Being tested
- RADIAQBIO Heart Guardian HR-501
- Medical subject headings
- Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RADIAQBIO Heart Guardian HR-501Device
Arm one offers ECG data and electric shocks recorded during AED operation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification ECG from patients
The AED identifies if ECG is VF or normal
Measured: during operating, approximately 2 hours
Secondary outcomes (1)
Survival patients by electric shock
Ratio of patients were survived after electric shock delivered
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start25 Mar 2016
- Primary completion8 Oct 2018
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest, SuddenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
- Target duration
- 32 Months
Sponsor and investigators
- Lead sponsor
- RadianQbio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969797
- Sponsor's protocol ID
- HR501_20190527
- Status last verified
- May 2019
- First submitted
- 27 May 2019
- Last updated
- 31 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Feedback of 19 Cases by AED Operation in Out-of-hospital Environment: a Prospective Randomized Log Analysis
- ClinicalTrials.gov ID
- NCT03969797
- Acronym / sponsor ID
- HR501_20190527
- Conditions
- Cardiac Arrest, Sudden
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- RadianQbioIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2016 (actual)
- Primary completion
- 8 Oct 2018 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 31 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 32 Months
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients using AED HR-501
Key inclusion criteria (2 listed)
- out-of-hospital cardiac arrest
- > 12 months
Key exclusion criteria (1 listed)
- age under 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RADIAQBIO Heart Guardian HR-501Arm one offers ECG data and electric shocks recorded during AED operation. | Device | – |
Primary outcome
Identification ECG from patients
Time frame: during operating, approximately 2 hours
The AED identifies if ECG is VF or normal
1 secondary outcome
Survival patients by electric shock
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, Sudden, run by RadianQbio at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification ECG from patients (time frame: during operating, approximately 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2019.