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

Not Applicable

• Conditions: Arrhythmias, Cardiac

• Registration Number: NCT04471584
• Lead Sponsor: Kansas City Heart Rhythm Research Foundation

Brief 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.

Study Timeline

• Study First Submitted: 2020-07-10
• Study First Submitted QC: 2020-07-10
• Study First Posted: 2020-07-15
• Study Start: 2020-09-21
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-22
• Last Update Posted: 2021-09-23
• Primary Completion: 2021-12
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Patients > 18 years of age with appropriate indication for ILR for atrial arrhythmia management.

Exclusion Criteria

Inability to give consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Positive predictive values of device detected atrial arrhythmias	12 months	Positive predictive values of device detected atrial arrhythmias

Trial Locations

Locations (1)

Kansas City Heart Rhythm Institute; 🇺🇸 Overland Park, Kansas, United States