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

Sponsor

Aga Khan University Hospital, Pakistan (Other)

Overall Status

Completed

CT.gov ID

NCT04957108

Collaborator

(none)

547

Enrollment

Location

Actual Duration (Months)

183

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrhythmia	Other: Device identification using Xray.

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

547 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official 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.

Actual Study Start Date :

Oct 1, 2020

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

All cardiac implantable devices

Assessed separately by Pacemaker ID app and cardia-x algorithm

Other: Device identification using Xray.

PMIDa and CRMD-f applications were used to identify CIED

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Aga Khan University	Karachi		Pakistan

Sponsors and Collaborators

Aga Khan University Hospital, Pakistan

Investigators

Principal Investigator: Yawer Saeed, MBBS, PHD, The Aga Khan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pirbhat Shams, Dr., Aga Khan University Hospital, Pakistan

ClinicalTrials.gov Identifier:

NCT04957108

Other Study ID Numbers:

2020-5101-14156

First Posted:

Jul 12, 2021

Last Update Posted:

Jul 12, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arrhythmias, Cardiac

Study Results

No Results Posted as of Jul 12, 2021