Comparative Analysis in Detection of Atrial Arrhythmia and ECG Quality in Three Different Insertable Cardiac Monitors
NCT ID: NCT04471584
Last Updated: 2021-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2020-09-21
2022-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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Abbott Confirm Rx
All patients randomized to this group will be implanted Abbott Confirm RX
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.
Medtronic Reveal LINQ
All patients randomized to this group will be implanted Medtronic Reveal LINQ
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.
Biotronik Biomonitor
All patients randomized to this group will be implanted Biotronik Biomonitor
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Kansas City Heart Rhythm Research Foundation
OTHER
Responsible Party
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Principal Investigators
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Dhanunjaya Lakkireddy
Role: PRINCIPAL_INVESTIGATOR
Kansas City Heart Rhythm Research Foundation
Locations
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Kansas City Heart Rhythm Institute
Overland Park, Kansas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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KCHRF-ILR-0003
Identifier Type: -
Identifier Source: org_study_id
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