Comparing Sensitivity and Specificity o… | Clinical Trial

Key information

Conditions

Cardiac Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

The Aga Khan University

Karachi, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Device identification using Xray.

Other

PMIDa and CRMD-f applications were used to identify CIED

Primary outcomes

Accuracy sensitivity, specificity, negative predictive value, and positive predictive value for both Pacemaker ID app and CRMD finder app.

Time frame: Upto 6 months of enrollment

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.

Secondary outcomes

sensitivity, specificity, negative predictive value, and positive predictive value for both Pacemaker ID app and CRMD finder app.

Time frame: Upto 6 months of enrollment

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.

Sponsors and collaborators

Lead sponsor

Aga Khan University Hospital, Pakistan

Other

Registry information

Official study title

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.

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Jul 12, 2021
Registry last updated: Jul 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed