<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/NCT02997254</url>
  </required_header>
  <id_info>
    <org_study_id>COMPARE_AF</org_study_id>
    <nct_id>NCT02997254</nct_id>
  </id_info>
  <brief_title>COMParison of Algorithms for Rotational Evaluation in Atrial Fibrillation</brief_title>
  <acronym>COMPARE_AF</acronym>
  <official_title>COMParison of Algorithms for Rotational Evaluation in Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a cohort study to evaluate algorithms for mapping atrial fibrillation by mapping&#xD;
      atrial structure and mapping electrical activity to detect focal and rotational activity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, the investigators will compare mapping approaches for atrial fibrillation&#xD;
      ablation.&#xD;
&#xD;
      First, investigators will compare approaches to map atrial structure from collected computed&#xD;
      tomography (CT) scans or magnetic resonance imaging (MRI) scans acquired routinely in&#xD;
      patients undergoing ablation for atrial fibrillation. Imaging will be acquired from a variety&#xD;
      of clinically approved&#xD;
&#xD;
      Second, investigators will compare approaches to analyze electrograms collected routinely at&#xD;
      clinical electrophysiology study (EPS) in patients undergoing ablation for atrial&#xD;
      fibrillation. Electrograms will be recorded from a variety of clinically approved catheters&#xD;
      under standard of care conditions, and will be analyzed to better understand the mechanisms&#xD;
      for atrial fibrillation and its relationship to outcomes.&#xD;
&#xD;
      The investigators anticipate analyzing data from 200 patients through December 2017.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Anticipated">November 30, 2026</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic Accuracy</measure>
    <time_frame>At the time of procedure</time_frame>
    <description>Comparing mapping systems to diagnose sites of importance in Atrial Fibrillation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnostic Accuracy</measure>
    <time_frame>At time of procedure.</time_frame>
    <description>Comparing algorithms to segment atrial structures from computed tomography or Magnetic resonance images.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Analysis Time</measure>
    <time_frame>At time of procedure.</time_frame>
    <description>Comparing time required to segment atrial structures from computed tomography or magnetic resonance images.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Abnormal Heart Rhythms</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The investigators will study adults aged 21-90 years who have undergone electrophysiology&#xD;
        study for ablation of Atrial Fibrillation. De-identified datasets will be made available&#xD;
        for comparisons of mapping approaches.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 21-80 yrs who underwent electrophysiology study for ablation of Atrial&#xD;
             Fibrillation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Poor data quality of recordings of AF&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sanjiv M Narayan, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sanjiv M Narayan, MD, PhD</last_name>
    <phone>(650) 723-9363</phone>
    <email>sanjiv1@stanford.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kathleen C Mills, BA</last_name>
    <phone>(650) 723-9363</phone>
    <email>kmills2@stanford.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gerri O'Riordan, RN</last_name>
      <phone>650-725-5597</phone>
      <email>GORiordan@stanfordhealthcare.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Narayan SM, Krummen DE, Shivkumar K, Clopton P, Rappel WJ, Miller JM. Treatment of atrial fibrillation by the ablation of localized sources: CONFIRM (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation) trial. J Am Coll Cardiol. 2012 Aug 14;60(7):628-36. doi: 10.1016/j.jacc.2012.05.022. Epub 2012 Jul 18.</citation>
    <PMID>22818076</PMID>
  </reference>
  <reference>
    <citation>Narayan SM, Krummen DE, Enyeart MW, Rappel WJ. Computational mapping identifies localized mechanisms for ablation of atrial fibrillation. PLoS One. 2012;7(9):e46034. doi: 10.1371/journal.pone.0046034. Epub 2012 Sep 26.</citation>
    <PMID>23049929</PMID>
  </reference>
  <reference>
    <citation>Benharash P, Buch E, Frank P, Share M, Tung R, Shivkumar K, Mandapati R. Quantitative analysis of localized sources identified by focal impulse and rotor modulation mapping in atrial fibrillation. Circ Arrhythm Electrophysiol. 2015 Jun;8(3):554-61. doi: 10.1161/CIRCEP.115.002721. Epub 2015 Apr 14.</citation>
    <PMID>25873718</PMID>
  </reference>
  <reference>
    <citation>Jalife J, Filgueiras Rama D, Berenfeld O. Letter by Jalife et al Regarding Article, &quot;Quantitative Analysis of Localized Sources Identified by Focal Impulse and Rotor Modulation Mapping in Atrial Fibrillation&quot;. Circ Arrhythm Electrophysiol. 2015 Oct;8(5):1296-8. doi: 10.1161/CIRCEP.115.003324. No abstract available.</citation>
    <PMID>26487627</PMID>
  </reference>
  <reference>
    <citation>Kuklik P, Zeemering S, Maesen B, Maessen J, Crijns HJ, Verheule S, Ganesan AN, Schotten U. Reconstruction of instantaneous phase of unipolar atrial contact electrogram using a concept of sinusoidal recomposition and Hilbert transform. IEEE Trans Biomed Eng. 2015 Jan;62(1):296-302. doi: 10.1109/TBME.2014.2350029. Epub 2014 Aug 20.</citation>
    <PMID>25148659</PMID>
  </reference>
  <reference>
    <citation>Kuklik P, Zeemering S, van Hunnik A, Maesen B, Pison L, Lau DH, Maessen J, Podziemski P, Meyer C, Schaffer B, Crijns H, Willems S, Schotten U. Identification of Rotors during Human Atrial Fibrillation Using Contact Mapping and Phase Singularity Detection: Technical Considerations. IEEE Trans Biomed Eng. 2017 Feb;64(2):310-318. doi: 10.1109/TBME.2016.2554660. Epub 2016 Apr 15.</citation>
    <PMID>27101596</PMID>
  </reference>
  <reference>
    <citation>Haissaguerre M, Hocini M, Denis A, Shah AJ, Komatsu Y, Yamashita S, Daly M, Amraoui S, Zellerhoff S, Picat MQ, Quotb A, Jesel L, Lim H, Ploux S, Bordachar P, Attuel G, Meillet V, Ritter P, Derval N, Sacher F, Bernus O, Cochet H, Jais P, Dubois R. Driver domains in persistent atrial fibrillation. Circulation. 2014 Aug 12;130(7):530-8. doi: 10.1161/CIRCULATIONAHA.113.005421. Epub 2014 Jul 15.</citation>
    <PMID>25028391</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>April 22, 2022</last_update_submitted>
  <last_update_submitted_qc>April 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Sanjiv Narayan, MD, PhD</investigator_full_name>
    <investigator_title>Professor of Medicine, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>atrial fibrillation</keyword>
  <keyword>ablation</keyword>
  <keyword>abnormal heart rhythm</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <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/NCT02997254
org study id: COMPARE_AF
nct id: NCT02997254
lead sponsor: 
has dmc: No
This is a cohort study to evaluate algorithms for mapping atrial fibrillation by mapping
      atrial structure and mapping electrical activity to detect focal and rotational activity.
In this study, the investigators will compare mapping approaches for atrial fibrillation
      ablation.

      First, investigators will compare approaches to map atrial structure from collected computed
      tomography (CT) scans or magnetic resonance imaging (MRI) scans acquired routinely in
      patients undergoing ablation for atrial fibrillation. Imaging will be acquired from a variety
      of clinically approved

      Second, investigators will compare approaches to analyze electrograms collected routinely at
      clinical electrophysiology study (EPS) in patients undergoing ablation for atrial
      fibrillation. Electrograms will be recorded from a variety of clinically approved catheters
      under standard of care conditions, and will be analyzed to better understand the mechanisms
      for atrial fibrillation and its relationship to outcomes.

      The investigators anticipate analyzing data from 200 patients through December 2017.
observational model: Cohort
time perspective: Retrospective
measure: Diagnostic Accuracy
time frame: At the time of procedure
description: Comparing mapping systems to diagnose sites of importance in Atrial Fibrillation
measure: Diagnostic Accuracy
time frame: At time of procedure.
description: Comparing algorithms to segment atrial structures from computed tomography or Magnetic resonance images.
measure: Analysis Time
time frame: At time of procedure.
description: Comparing time required to segment atrial structures from computed tomography or magnetic resonance images.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 90 Years
healthy volunteers: No
last name: Sanjiv M Narayan, MD, PhD
role: Principal Investigator
affiliation: Stanford University
last name: Sanjiv M Narayan, MD, PhD
phone: (650) 723-9363
email: sanjiv1@stanford.edu
last name: Kathleen C Mills, BA
phone: (650) 723-9363
email: kmills2@stanford.edu
facility: 
status: Recruiting
contact: 
country: United States
citation: Narayan SM, Krummen DE, Shivkumar K, Clopton P, Rappel WJ, Miller JM. Treatment of atrial fibrillation by the ablation of localized sources: CONFIRM (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation) trial. J Am Coll Cardiol. 2012 Aug 14;60(7):628-36. doi: 10.1016/j.jacc.2012.05.022. Epub 2012 Jul 18.
PMID: 22818076
citation: Narayan SM, Krummen DE, Enyeart MW, Rappel WJ. Computational mapping identifies localized mechanisms for ablation of atrial fibrillation. PLoS One. 2012;7(9):e46034. doi: 10.1371/journal.pone.0046034. Epub 2012 Sep 26.
PMID: 23049929
citation: Benharash P, Buch E, Frank P, Share M, Tung R, Shivkumar K, Mandapati R. Quantitative analysis of localized sources identified by focal impulse and rotor modulation mapping in atrial fibrillation. Circ Arrhythm Electrophysiol. 2015 Jun;8(3):554-61. doi: 10.1161/CIRCEP.115.002721. Epub 2015 Apr 14.
PMID: 25873718
citation: Jalife J, Filgueiras Rama D, Berenfeld O. Letter by Jalife et al Regarding Article, "Quantitative Analysis of Localized Sources Identified by Focal Impulse and Rotor Modulation Mapping in Atrial Fibrillation". Circ Arrhythm Electrophysiol. 2015 Oct;8(5):1296-8. doi: 10.1161/CIRCEP.115.003324. No abstract available.
PMID: 26487627
citation: Kuklik P, Zeemering S, Maesen B, Maessen J, Crijns HJ, Verheule S, Ganesan AN, Schotten U. Reconstruction of instantaneous phase of unipolar atrial contact electrogram using a concept of sinusoidal recomposition and Hilbert transform. IEEE Trans Biomed Eng. 2015 Jan;62(1):296-302. doi: 10.1109/TBME.2014.2350029. Epub 2014 Aug 20.
PMID: 25148659
citation: Kuklik P, Zeemering S, van Hunnik A, Maesen B, Pison L, Lau DH, Maessen J, Podziemski P, Meyer C, Schaffer B, Crijns H, Willems S, Schotten U. Identification of Rotors during Human Atrial Fibrillation Using Contact Mapping and Phase Singularity Detection: Technical Considerations. IEEE Trans Biomed Eng. 2017 Feb;64(2):310-318. doi: 10.1109/TBME.2016.2554660. Epub 2016 Apr 15.
PMID: 27101596
citation: Haissaguerre M, Hocini M, Denis A, Shah AJ, Komatsu Y, Yamashita S, Daly M, Amraoui S, Zellerhoff S, Picat MQ, Quotb A, Jesel L, Lim H, Ploux S, Bordachar P, Attuel G, Meillet V, Ritter P, Derval N, Sacher F, Bernus O, Cochet H, Jais P, Dubois R. Driver domains in persistent atrial fibrillation. Circulation. 2014 Aug 12;130(7):530-8. doi: 10.1161/CIRCULATIONAHA.113.005421. Epub 2014 Jul 15.
PMID: 25028391
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Sanjiv Narayan, MD, PhD
investigator title: Professor of Medicine, Principal Investigator
mesh term: Atrial Fibrillation
mesh term: Arrhythmias, Cardiac
sharing ipd: No