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

Primary Purpose

Arrhythmias, Cardiac

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Insertion of ILR device
Sponsored by
Kansas City Heart Rhythm Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Arrhythmias, Cardiac focused on measuring Cardiac Arrhythmias, Implantable loop recorder, Comparative Analysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Inability to give consent

Sites / Locations

  • Kansas City Heart Rhythm InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Abbott Confirm Rx

Medtronic Reveal LINQ

Biotronik Biomonitor

Arm Description

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

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

All patients randomized to this group will be implanted Biotronik Biomonitor

Outcomes

Primary Outcome Measures

Positive predictive values of device detected atrial arrhythmias
Positive predictive values of device detected atrial arrhythmias

Secondary Outcome Measures

Full Information

First Posted
July 10, 2020
Last Updated
September 22, 2021
Sponsor
Kansas City Heart Rhythm Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04471584
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kansas City Heart Rhythm Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmias, Cardiac
Keywords
Cardiac Arrhythmias, Implantable loop recorder, Comparative Analysis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Abbott Confirm Rx
Arm Type
Active Comparator
Arm Description
All patients randomized to this group will be implanted Abbott Confirm RX
Arm Title
Medtronic Reveal LINQ
Arm Type
Active Comparator
Arm Description
All patients randomized to this group will be implanted Medtronic Reveal LINQ
Arm Title
Biotronik Biomonitor
Arm Type
Active Comparator
Arm Description
All patients randomized to this group will be implanted Biotronik Biomonitor
Intervention Type
Device
Intervention Name(s)
Insertion of ILR device
Intervention Description
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 Information:
Title
Positive predictive values of device detected atrial arrhythmias
Description
Positive predictive values of device detected atrial arrhythmias
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients > 18 years of age with appropriate indication for ILR for atrial arrhythmia management. Exclusion Criteria: Inability to give consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donita Atkins
Phone
816-651-1969
Email
datkins@kchrf.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dhanunjaya Lakkireddy
Organizational Affiliation
Kansas City Heart Rhythm Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kansas City Heart Rhythm Institute
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donita Atkins
Phone
816-651-1969
Email
datkins@kchrf.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20937748
Citation
Parry SW, Matthews IG. Implantable loop recorders in the investigation of unexplained syncope: a state of the art review. Heart. 2010 Oct;96(20):1611-6. doi: 10.1136/hrt.2010.193417.
Results Reference
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PubMed Identifier
23701932
Citation
Palmisano P, Accogli M, Zaccaria M, Luzzi G, Nacci F, Anaclerio M, Favale S. Predictive factors for pacemaker implantation in patients receiving an implantable loop recorder for syncope remained unexplained after an extensive cardiac and neurological workup. Int J Cardiol. 2013 Oct 9;168(4):3450-7. doi: 10.1016/j.ijcard.2013.04.179. Epub 2013 May 20.
Results Reference
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PubMed Identifier
26319443
Citation
Pecha S, Aydin MA, Ahmadzade T, Hartel F, Hoffmann B, Steven D, Willems S, Reichenspurner H, Wagner FM. Implantable loop recorder monitoring after concomitant surgical ablation for atrial fibrillation (AF): insights from more than 200 continuously monitored patients. Heart Vessels. 2016 Aug;31(8):1347-53. doi: 10.1007/s00380-015-0735-4. Epub 2015 Aug 29.
Results Reference
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PubMed Identifier
23577826
Citation
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Results Reference
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PubMed Identifier
27796409
Citation
Lauschke J, Busch M, Haverkamp W, Bulava A, Schneider R, Andresen D, Nagele H, Israel C, Hindricks G, Bansch D. New implantable cardiac monitor with three-lead ECG and active noise detection. Herz. 2017 Sep;42(6):585-592. doi: 10.1007/s00059-016-4492-7. Epub 2016 Oct 28.
Results Reference
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PubMed Identifier
27565119
Citation
Nolker G, Mayer J, Boldt LH, Seidl K, VAN Driel V, Massa T, Kollum M, Brachmann J, Deneke T, Hindricks G, Jung W, Brunner KJ, Kraus S, Hummer A, Lewalter T. Performance of an Implantable Cardiac Monitor to Detect Atrial Fibrillation: Results of the DETECT AF Study. J Cardiovasc Electrophysiol. 2016 Dec;27(12):1403-1410. doi: 10.1111/jce.13089. Epub 2016 Oct 7.
Results Reference
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PubMed Identifier
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Citation
Ciconte G, Saviano M, Giannelli L, Calovic Z, Baldi M, Ciaccio C, Cuko A, Vitale R, Giacopelli D, Conti M, Lipartiti F, Giordano F, Maresca F, Moscatiello M, Vicedomini G, Santinelli V, Pappone C. Atrial fibrillation detection using a novel three-vector cardiac implantable monitor: the atrial fibrillation detect study. Europace. 2017 Jul 1;19(7):1101-1108. doi: 10.1093/europace/euw181.
Results Reference
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PubMed Identifier
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Citation
Hindricks G, Pokushalov E, Urban L, Taborsky M, Kuck KH, Lebedev D, Rieger G, Purerfellner H; XPECT Trial Investigators. Performance of a new leadless implantable cardiac monitor in detecting and quantifying atrial fibrillation: Results of the XPECT trial. Circ Arrhythm Electrophysiol. 2010 Apr;3(2):141-7. doi: 10.1161/CIRCEP.109.877852. Epub 2010 Feb 16.
Results Reference
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Citation
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Results Reference
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Comparative Analysis in Detection of Atrial Arrhythmia and ECG Quality in Three Different Insertable Cardiac Monitors

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