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出境医 / 临床实验 / AED Log Analysis of 19 Cases in Out-of-hospital Environment
AED Log Analysis of 19 Cases in Out-of-hospital Environment
Study Description
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Cardiac Arrest, Sudden | Device: RADIAQBIO Heart Guardian HR-501 |
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
| Study Type : | Observational [Patient Registry] |
| Actual Enrollment : | 19 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 32 Months |
| Official Title: | Quality Feedback of 19 Cases by AED Operation in Out-of-hospital Environment: a Prospective Randomized Log Analysis |
| Actual Study Start Date : | March 25, 2016 |
| Actual Primary Completion Date : | October 8, 2018 |
| Actual Study Completion Date : | January 15, 2019 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Identification ECG from patients [ Time Frame: during operating, approximately 2 hours ]The AED identifies if ECG is VF or normal
Secondary Outcome Measures :
- Survival patients by electric shock [ Time Frame: 24 hours ]Ratio of patients were survived after electric shock delivered
Eligibility Criteria
Contacts and Locations
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 27, 2019 | ||||
| First Posted Date | May 31, 2019 | ||||
| Last Update Posted Date | May 31, 2019 | ||||
| Actual Study Start Date | March 25, 2016 | ||||
| Actual Primary Completion Date | October 8, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Identification ECG from patients [ Time Frame: during operating, approximately 2 hours ] The AED identifies if ECG is VF or normal
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
Survival patients by electric shock [ Time Frame: 24 hours ] Ratio of patients were survived after electric shock delivered
|
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | AED Log Analysis of 19 Cases in Out-of-hospital Environment | ||||
| Official Title | Quality Feedback of 19 Cases by AED Operation in Out-of-hospital Environment: a Prospective Randomized Log Analysis | ||||
| 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. | ||||
| Study Type | Observational [Patient Registry] | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | 32 Months | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients using AED HR-501 | ||||
| Condition | Cardiac Arrest, Sudden | ||||
| Intervention | Device: RADIAQBIO Heart Guardian HR-501
Arm one offers ECG data and electric shocks recorded during AED operation.
|
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| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
19 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | January 15, 2019 | ||||
| Actual Primary Completion Date | October 8, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 1 Year and older (Child, Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Korea, Republic of | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03969797 | ||||
| Other Study ID Numbers | HR501_20190527 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement |
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| Responsible Party | RadianQbio | ||||
| Study Sponsor | RadianQbio | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | RadianQbio | ||||
| Verification Date | May 2019 | ||||
