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

NCT04957108 | Completed DMC

• 1 other identifier: 2020-5101-14156
• Study Type: observational
• Target: 547
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrhythmia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Upto 6 months of enrollment

Study Arms (1)

All cardiac implantable devices

Assessed separately by Pacemaker ID app and cardia-x algorithm

Other: Device identification using Xray.

Interventions

Device identification using Xray. OTHER

PMIDa and CRMD-f applications were used to identify CIED

All cardiac implantable devices

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing CIED implantation and having post-device Xray were included.

You may qualify if:

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

You may not qualify if:

• Patients with CIED for whome Xray was not available.

Sponsors & Collaborators

• Aga Khan University Hospital, Pakistan: lead

Study Sites (1)

The Aga Khan University

Karachi, Pakistan

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yawer Saeed, MBBS, PHD

  The Aga Khan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 12, 2021
• Study Start: October 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 12, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)