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

Kansas City Heart Rhythm Research Foundation

Status: Unknown

Conditions: Arrhythmias, Cardiac

Treatments: Device: Insertion of ILR device

Study type: Interventional

Funder types: Other

Identifiers

NCT04471584

KCHRF-ILR-0003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Inability to give consent

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Abbott Confirm Rx

Active Comparator group

Description:

All patients randomized to this group will be implanted Abbott Confirm RX

Treatment:

Device: Insertion of ILR device

Medtronic Reveal LINQ

Active Comparator group

Description:

All patients randomized to this group will be implanted Medtronic Reveal LINQ

Treatment:

Device: Insertion of ILR device

Biotronik Biomonitor

Active Comparator group

Description:

All patients randomized to this group will be implanted Biotronik Biomonitor

Treatment:

Device: Insertion of ILR device