Recruiting

Cardiac Monitors

Sponsor:

Kansas City Heart Rhythm Research Foundation

Code:

NCT04471584

Conditions

Arrhythmias, Cardiac

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Insertion of ILR device

Study Details

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.

Conditions

Arrhythmias, Cardiac

Study ID

NCT04471584

Start date

Sep 21, 2020

Status verified date

Sep, 2021

Completion date

Mar, 2022

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

Inability to give consent

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Abbott Confirm Rx

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

active comparator: Medtronic Reveal LINQ

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

active comparator: Biotronik Biomonitor

All patients randomized to this group will be implanted Biotronik Biomonitor

Interventions

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.

Primary outcome measure

  • Positive predictive values of device detected atrial arrhythmias [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Donita Atkins

816-651-1969datkins@kchrf.com

Locations

Kansas City Heart Rhythm Institute

Recruiting

Overland Park, Kansas, United States, 66211

Contacts

Donita Atkins

816-651-1969datkins@kchrf.com

More Information

Sponsor

Kansas City Heart Rhythm Research Foundation

Last update posted

Sep 23, 2021

Last verified

Sep, 2021

Keywords

  • Cardiac Arrhythmias
  • Implantable loop recorder
  • Comparative Analysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kansas City Heart Rhythm Research Foundation on 2021-09-23.