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临床试验/NCT04957108
NCT04957108已完成不适用

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.

Aga Khan University Hospital, Pakistan1 个研究点 分布在 1 个国家目标入组 547 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
547
试验地点
1
主要终点
Accuracy sensitivity, specificity, negative predictive value, and positive predictive value for both Pacemaker ID app and CRMD finder app.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients undergoing CIED implantation and having xray post-implant at any point and time.

排除标准

  • Patients with CIED for whome Xray was not available.

结局指标

主要结局

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

时间窗: 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.

次要结局

  • sensitivity, specificity, negative predictive value, and positive predictive value for both Pacemaker ID app and CRMD finder app.(Upto 6 months of enrollment)

研究者

发起方
Aga Khan University Hospital, Pakistan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pirbhat Shams

Dr.

Aga Khan University Hospital, Pakistan

研究点 (1)

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