Clinical trial NCT04471584: Comparative Analysis in Detection of Atrial Arrhythmia and ECG Quality in Three Different Insertable Cardiac Monitors
Official title: Comparative Analysis in Detection of Atrial Arrhythmia and Electrogram Quality in Three Different Insertable Cardiac Monitors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arrhythmias, Cardiac
Keywords: Cardiac Arrhythmias
Implantable loop recorder
Comparative Analysis
Lead sponsor: Kansas City Heart Rhythm Research Foundation
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Inability to give consent

Primary outcomes:
measure: Positive predictive values of device detected atrial arrhythmias
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Kansas City Heart Rhythm Institute
state: Kansas
Study officials:
affiliation: Kansas City Heart Rhythm Research Foundation
name: Dhanunjaya Lakkireddy
role: PRINCIPAL_INVESTIGATOR
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