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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04471584
Enrollment
150
Registered
2020-07-15
Start date
2020-09-21
Completion date
2022-03-31
Last updated
2021-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmias, Cardiac

Keywords

Cardiac Arrhythmias, Implantable loop recorder, Comparative Analysis

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.

Interventions

DEVICEInsertion 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.

Sponsors

Kansas City Heart Rhythm Research Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Inability to give consent

Design outcomes

Primary

MeasureTime frameDescription
Positive predictive values of device detected atrial arrhythmias12 monthsPositive predictive values of device detected atrial arrhythmias

Countries

United States

Contacts

Primary ContactDonita Atkins
datkins@kchrf.com816-651-1969

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026