<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04471584</url>
  </required_header>
  <id_info>
    <org_study_id>KCHRF-ILR-0003</org_study_id>
    <nct_id>NCT04471584</nct_id>
  </id_info>
  <brief_title>Comparative Analysis in Detection of Atrial Arrhythmia and ECG Quality in Three Different Insertable Cardiac Monitors</brief_title>
  <official_title>Comparative Analysis in Detection of Atrial Arrhythmia and Electrogram Quality in Three Different Insertable Cardiac Monitors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kansas City Heart Rhythm Research Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kansas City Heart Rhythm Research Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparative analysis of available ILR devices models Abbot Confirm RxTM, Medtronic Reveal&#xD;
      LINQTM, and Biotronik BIOMONITOR., evaluating detection performance and effective of&#xD;
      transmission of these devices to better understand the differences between them.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All devices have different algorithms for arrhythmia detection and structural design.&#xD;
      Consequently, these devices vary in sensitivity of arrhythmia detection and data&#xD;
      transmission.Therefore, we aim to expand a comparative analysis of available devices,&#xD;
      evaluating detection performance and effective of transmission of these devices to better&#xD;
      understand the differences between them.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 21, 2020</start_date>
  <completion_date type="Anticipated">March 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Positive predictive values of device detected atrial arrhythmias</measure>
    <time_frame>12 months</time_frame>
    <description>Positive predictive values of device detected atrial arrhythmias</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Arrhythmias, Cardiac</condition>
  <arm_group>
    <arm_group_label>Abbott Confirm Rx</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All patients randomized to this group will be implanted Abbott Confirm RX</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medtronic Reveal LINQ</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All patients randomized to this group will be implanted Medtronic Reveal LINQ</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biotronik Biomonitor</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All patients randomized to this group will be implanted Biotronik Biomonitor</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Insertion of ILR device</intervention_name>
    <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.</description>
    <arm_group_label>Abbott Confirm Rx</arm_group_label>
    <arm_group_label>Biotronik Biomonitor</arm_group_label>
    <arm_group_label>Medtronic Reveal LINQ</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients &gt; 18 years of age with appropriate indication for ILR for atrial arrhythmia&#xD;
        management.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Inability to give consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dhanunjaya Lakkireddy</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kansas City Heart Rhythm Research Foundation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Donita Atkins</last_name>
    <phone>816-651-1969</phone>
    <email>datkins@kchrf.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kansas City Heart Rhythm Institute</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66211</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Donita Atkins</last_name>
      <phone>816-651-1969</phone>
      <email>datkins@kchrf.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>20937748</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23701932</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26319443</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23577826</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>27796409</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>27565119</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>27702865</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>20160169</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>28919290</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>September 22, 2021</last_update_submitted>
  <last_update_submitted_qc>September 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiac Arrhythmias</keyword>
  <keyword>Implantable loop recorder</keyword>
  <keyword>Comparative Analysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04471584
org study id: KCHRF-ILR-0003
nct id: NCT04471584
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
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.
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.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Other
masking: None (Open Label)
measure: Positive predictive values of device detected atrial arrhythmias
time frame: 12 months
description: Positive predictive values of device detected atrial arrhythmias
arm group label: Abbott Confirm Rx
arm group type: Active Comparator
description: All patients randomized to this group will be implanted Abbott Confirm RX
arm group label: Medtronic Reveal LINQ
arm group type: Active Comparator
description: All patients randomized to this group will be implanted Medtronic Reveal LINQ
arm group label: Biotronik Biomonitor
arm group type: Active Comparator
description: All patients randomized to this group will be implanted Biotronik Biomonitor
intervention type: Device
intervention name: Insertion of ILR device
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.
arm group label: Abbott Confirm Rx
arm group label: Biotronik Biomonitor
arm group label: Medtronic Reveal LINQ
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dhanunjaya Lakkireddy
role: Principal Investigator
affiliation: Kansas City Heart Rhythm Research Foundation
last name: Donita Atkins
phone: 816-651-1969
email: datkins@kchrf.com
facility: 
status: Recruiting
contact: 
country: United States
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.
PMID: 20937748
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.
PMID: 23701932
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.
PMID: 26319443
citation: 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: 23577826
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.
PMID: 27796409
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.
PMID: 27565119
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.
PMID: 27702865
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.
PMID: 20160169
citation: 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: 28919290
responsible party type: Sponsor
mesh term: Arrhythmias, Cardiac
sharing ipd: No