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

September 22, 2021 updated by: Kansas City Heart Rhythm Research Foundation

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • Kansas City Heart Rhythm Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

Inability to give consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Abbott Confirm Rx
All patients randomized to this group will be implanted Abbott Confirm RX
Device: 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.
Active Comparator: Medtronic Reveal LINQ
All patients randomized to this group will be implanted Medtronic Reveal LINQ
Device: 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.
Active Comparator: Biotronik Biomonitor
All patients randomized to this group will be implanted Biotronik Biomonitor
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive predictive values of device detected atrial arrhythmias
Time Frame: 12 months
Positive predictive values of device detected atrial arrhythmias
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kansas City Heart Rhythm Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2020

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

July 10, 2020

First Submitted That Met QC Criteria

July 10, 2020

First Posted (Actual)

July 15, 2020

Study Record Updates

Last Update Posted (Actual)

September 23, 2021

Last Update Submitted That Met QC Criteria

September 22, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCHRF-ILR-0003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arrhythmias, Cardiac

Clinical Trials on Insertion of ILR device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe