Atrial Fibrillation Detecting Software Gung Atrial Fibril... | NCT05872516

Studies
Atrial Fibrillation Detecting Software Gung Atrial Fibrillation Detecting Software

NCT05872516

Sponsor

Chang Gung Memorial Hospital

Status

Completed

Last Update Posted

May 24, 2023Actual

Enrollment

788Actual

Phase

Not Applicable

Conditions

Atrial Fibrillation

Interventions

Chang Gung Atrial Fibrillation Detecting Software

Countries

Taiwan

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

Apr 2023

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

Jul 11, 2022Actual

Primary Completion Date

Feb 8, 2023Actual

Completion Date

Apr 10, 2023Actual

First Submitted Date

May 4, 2023

First Submission Date that Met QC Criteria

May 14, 2023

First Posted Date

May 24, 2023Actual

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 14, 2023

Last Update Posted Date

May 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Chang Gung Atrial Fibrillation Detection Software is an artificial intelligence electrocardiogram signal analysis software that detects whether a patient has atrial fibrillation by static 12-lead ECG signals. This study is a non-inferiority test based on the control group. The main purpose is to verify whether Chang Gung atrial fibrillation detection software can correctly identify atrial fibrillation in patients with atrial fibrillation, and can be used to provide a reference for doctors to detect atrial fibrillation.

Detailed Description

This study is a retrospective study, and the data is from the six hospitals of Chang Gung Medical Research Database (CGRD). We collected de-identified static 12-lead electrocardiogram (ECG) data from the database during the period of January 1, 2006, to December 31, 2019.

We created a training set and a testing set of ECG data from the CGRD. Then, we stratified and sampled ECG signals from the testing set according to the actual proportion to obtain the experimental sample.

The computer first preliminarily screened and selected ECG data that met the inclusion and exclusion criteria, and then numbered them sequentially. A cardiologist confirmed that the sampled ECG data did not include exclusion criteria.

The ECG data were converted into images and interpreted for the presence or absence of atrial fibrillation by three cardiologists. Their results were used as the gold standard (reference) for this study.

After determining the experimental standards, the ECG signals were inputted into the Chang Gung Atrial Fibrillation Detection software for analysis and interpretation of each ECG data.

After the software interpretation was completed, the results were compared with the interpretations of the physicians, and the primary and secondary evaluation indicators were analyzed accordingly.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

788Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Software diagnosis	Experimental	Software diagnosis with gold standard of 3 doctors' consensus.	Device: Chang Gung Atrial Fibrillation Detecting Software

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chang Gung Atrial Fibrillation Detecting Software	Device	This software is expected to be used in clinical testing to interpret the static 12-lead ECG of adults who are over 20 years old and suspected of having atrial fibrillation, detect whether there is a signal of atrial fibrillation, and output the results for clinicians Near-instant auxiliary diagnostic use.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity	The rate of test results that correctly indicate the presence.	baseline

Secondary Outcomes

Measure	Description	Time Frame
Specificity	The rate of test results that correctly indicate the absence.	baseline
Accuracy	The rate of all test results that correctly indicate.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Equal or greater than twenty years old
Static 12-lead electrocardiogram of General Electric MUSE XML format file.
The data comes from the static 12-lead electrocardiogram device of General Electric (model MAC5500).
The electrocardiogram signal is 500 Hz.
The Alternating current (AC) filter of the electrocardiogram signal is 60 Hz.

Exclusion Criteria:

Cases used in the model development process.
Lacks any electrode.
Contain any electrode lacks a segment.
Misplaced leads

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chang-Fu Kuo, MD/Ph.D	Associate Professor and Director Division of Rheumatology	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chang Gung memorial hospital		Taoyuan City		333	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17604299	Background	Mant J, Fitzmaurice DA, Hobbs FD, Jowett S, Murray ET, Holder R, Davies M, Lip GY. Accuracy of diagnosing atrial fibrillation on electrocardiogram by primary care practitioners and interpretative diagnostic software: analysis of data from screening for atrial fibrillation in the elderly (SAFE) trial. BMJ. 2007 Aug 25;335(7616):380. doi: 10.1136/bmj.39227.551713.AE. Epub 2007 Jun 29.
30088016

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes