Comparing Sensitivity and Specificity of Pacemaker ID Application and Cardiac Rhythm Management Device-Finder Application.

Study Overview
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Brief Summary
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Smart phone-based applications to identify cardiac implantable electronic devices (CIED) are extremely useful in circumstances where urgent device interrogation is needed and device identification card is not available. Few studies have provided insight regarding the utility of these applications. We have studied two widely available applications i.e., Pacemaker ID app (PMIDa) or Cardiac Rhythm Management Devices-Finder (CRMD-f) to identiy device manufacturers in CIEDs.

Detailed Description
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Smart phone-based applications to identify cardiac implantable electronic devices (CIED) are extremely useful in circumstances where urgent device interrogation is needed and device identification card is not available. Few studies have provided insight regarding the utility of these applications. We have studied two widely available applications i.e., Pacemaker ID app (PMIDa) or Cardiac Rhythm Management Devices-Finder (CRMD-f) to identiy device manufacturers in CIEDs. 547 patients who underwent CIED implantation from year 2016 - 2020 in our institute were enrolled. There were 438 Medtronic and 109 St. Jude's devices. All chest radiographs were de-identified and resized into 225*225 pixels focusing on the CIED. PMIDa and CRMD-f applications were used to identify CIED. Accuracy, sensitivity, specificity, negative predictive value, and positive predictive value for both applications were calculated and compared.

Official Title
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Comparing Sensitivity and Specificity of Pacemaker ID Application and Cardiac Rhythm Management Device-Finder Application in Identifying Cardiac Implantable Electronic Device Manufacturer Using Chest Radiograph - an Observational Study.

Conditions
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Cardiac Arrhythmia

Intervention / Treatment
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* Other: Device identification using Xray.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients undergoing CIED implantation and having xray post-implant at any point and time. Exclusion Criteria: Patients with CIED for whome Xray was not available.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All cardiac implantable devices<br>Assessed separately by Pacemaker ID app and cardia-x algorithm | Other: Device identification using Xray.<br>* PMIDa and CRMD-f applications were used to identify CIED<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy sensitivity, specificity, negative predictive value, and positive predictive value for both Pacemaker ID app and CRMD finder app. | Accuracy, sensitivity, specificity, negative predictive value, and positive predictive value for both Pacemaker ID app and CRMD finder app. Above mentioned values shall be calculated after analysing data in SPSS and doing cross tabulation. Values will be in percentages. | Upto 6 months of enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity, specificity, negative predictive value, and positive predictive value for both Pacemaker ID app and CRMD finder app. | sensitivity, specificity, negative predictive value, and positive predictive value for both Pacemaker ID app and CRMD finder app. Above mentioned values shall be calculated after analysing data in SPSS and doing cross tabulation. Values will be in percentages. | Upto 6 months of enrollment |