NCT04471584

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 21, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

1.2 years

First QC Date

July 10, 2020

Last Update Submit

September 22, 2021

Conditions

Arrhythmias, Cardiac

Keywords

Cardiac ArrhythmiasImplantable loop recorderComparative Analysis

Outcome Measures

Primary Outcomes (1)

  • Positive predictive values of device detected atrial arrhythmias

    Positive predictive values of device detected atrial arrhythmias

    12 months

Study Arms (3)

Abbott Confirm Rx

ACTIVE COMPARATOR

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

Device: Insertion of ILR device

Medtronic Reveal LINQ

ACTIVE COMPARATOR

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

Device: Insertion of ILR device

Biotronik Biomonitor

ACTIVE COMPARATOR

All patients randomized to this group will be implanted Biotronik Biomonitor

Device: Insertion of ILR device

Interventions

Insertion of ILR deviceDEVICE

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.

Abbott Confirm RxBiotronik BiomonitorMedtronic Reveal LINQ

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Inability to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kansas City Heart Rhythm Institute

Overland Park, Kansas, 66211, United States

RECRUITING

Related Publications (9)

  • 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.

    PMID: 20937748BACKGROUND

  • 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.

    PMID: 23701932BACKGROUND

  • 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.

    PMID: 26319443BACKGROUND

  • Kapa S, Epstein AE, Callans DJ, Garcia FC, Lin D, Bala R, Riley MP, Hutchinson MD, Gerstenfeld EP, Tzou W, Marchlinski FE, Frankel DS, Cooper JM, Supple G, Deo R, Verdino RJ, Patel VV, Dixit S. Assessing arrhythmia burden after catheter ablation of atrial fibrillation using an implantable loop recorder: the ABACUS study. J Cardiovasc Electrophysiol. 2013 Aug;24(8):875-81. doi: 10.1111/jce.12141. Epub 2013 Apr 11.

    PMID: 23577826BACKGROUND

  • 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.

    PMID: 27796409BACKGROUND

  • 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.

    PMID: 27565119BACKGROUND

  • 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.

    PMID: 27702865BACKGROUND

  • 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.

    PMID: 20160169BACKGROUND

  • Lee R, Mittal S. Utility and limitations of long-term monitoring of atrial fibrillation using an implantable loop recorder. Heart Rhythm. 2018 Feb;15(2):287-295. doi: 10.1016/j.hrthm.2017.09.009. Epub 2017 Sep 13.

    PMID: 28919290BACKGROUND

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dhanunjaya Lakkireddy

    Kansas City Heart Rhythm Research Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Donita Atkins

CONTACT

816-651-1969datkins@kchrf.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2020

First Posted

July 15, 2020

Study Start

September 21, 2020

Primary Completion

December 1, 2021

Study Completion

March 1, 2022

Last Updated

September 23, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)