NCT04471584

Comparative Analysis in Detection of Atrial Arrhythmia and ECG Quality in Three Different Insertable Cardiac Monitors

Comparative Analysis in Detection of Atrial Arrhythmia and Electrogram Quality in Three Different Insertable Cardiac Monitors

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Kansas City Heart Rhythm Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Comparative analysis of available ILR devices models Abbot Confirm RxTM, Medtronic Reveal LINQTM, and Biotronik BIOMONITOR., evaluating detection performance and effective of transmission of these devices to better understand the differences between them.

Detailed description

All devices have different algorithms for arrhythmia detection and structural design. Consequently, these devices vary in sensitivity of arrhythmia detection and data transmission.Therefore, we aim to expand a comparative analysis of available devices, evaluating detection performance and effective of transmission of these devices to better understand the differences between them.

Conditions

• Arrhythmias, Cardiac

Interventions

Type	Name	Description
DEVICE	Insertion of ILR device	All patients enrolled will be randomized to have one of three ILR devices implanted (BIOMONITOR III, Reveal LinQ, or Confirm RX) and will be given event monitoring device for concurrent evaluation.

Timeline

• Start date: 2020-09-21
• Primary completion: 2021-12-01
• Completion: 2022-03-01
• First posted: 2020-07-15
• Last updated: 2021-09-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study