xml: <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/NCT06023888</url>
    </required_header>
    <id_info>
      <org_study_id>2022-12-009C</org_study_id>
      <nct_id>NCT06023888</nct_id>
    </id_info>
    <brief_title>Waveform Periodicity Analysis in Patients With Persistent Atrial Fibrillation</brief_title>
    <official_title>A Prospective Randomized Controlled Study on the Waveform Periodicity Analysis of Complex Fractionated Electrograms With OctaRay in Patients With Persistent Atrial Fibrillation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Taipei Veterans General Hospital, Taiwan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Taipei Veterans General Hospital, Taiwan</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        STUDY DESIGN A prospective study.&#xD;
  &#xD;
        OBJECTIVE A single center clinical trial on the analysis of intracardiac atrial electrogram&#xD;
        waveform periodicity for catheter ablation of persistent atrial fibrillation with OCTARAY™&#xD;
        Mapping Catheter, as prospective randomized controlled study.&#xD;
  &#xD;
        HYPOTHESIS:&#xD;
  &#xD;
        The critical atrial substrates in maintaining persistent atrial fibrillation could be&#xD;
        identified by non-linear electrogram morphology analysis in a point-by-point electroanatomic&#xD;
        mapping. Based on the previous study, atrial substrate with high-similarity electrogram&#xD;
        regions correlated with procedural AF termination and better long-term AF-free (1).&#xD;
        Therefore, we proposed that the degree of waveform similarity plus the beat-to-beat&#xD;
        sequential morphology (2) (duration of how many similar waveforms can maintain in sequence)&#xD;
        would be even better to characterize the atrial substrate and could be potentially critical&#xD;
        atrial substrate in prediction of sources of AF. As additional substrate mapping provided&#xD;
        benefits compared to PVI alone in patients with persistent AF, we hypothesize that waveform&#xD;
        periodicity adjuvant to electrogram similarity and phase mapping could be used to guide&#xD;
        radiofrequency ablation in real time. The used of the OCTARAY™ Mapping Catheter could&#xD;
        collected more AF electrogram and facilitate the mapping resolution and driver&#xD;
        identification.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 9, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2025</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>Parallel Assignment</intervention_model>
      <intervention_model_description>This study was designed to determine the efficacy of substrate ablation using waveform periodicity analysis, similarity analysis with OCTARAY™ Mapping Catheter could collected more AF electrogram and facilitate the mapping resolution and driver identification., plus phase mapping in persistent AF patients who required substrate modification.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Recurrence of atrial arrhythmia</measure>
      <time_frame>up to 6 month</time_frame>
      <description>atrial arrhythmia in 24-hour monitoring</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Recurrence of atrial arrhythmia</measure>
      <time_frame>up to 1 year</time_frame>
      <description>atrial arrhythmia in 7-day ECG monitoring</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Atrial Fibrillation</condition>
    <arm_group>
      <arm_group_label>Periodicity-based</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Standard ablation strategy as usual</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Mapping strategy</intervention_name>
      <description>The ablation strategy was based on the mapping results of periodicity.</description>
      <arm_group_label>Periodicity-based</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Mapping strategy</intervention_name>
      <description>PVI+ non-PV trigger</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  persistent atrial fibrillation&#xD;
  &#xD;
            -  refractory or intolerant to medication&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previous AF ablation&#xD;
  &#xD;
            -  LA thrombus&#xD;
  &#xD;
            -  Previous MAZE procedure&#xD;
  &#xD;
            -  Poor renal function&#xD;
  &#xD;
            -  Can't follow-up for one year&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>CHIN-YU LIN, DR</last_name>
      <phone>+886983215656</phone>
      <email>clouaa@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Taipei Veterans General Hospital</name>
        <address>
          <city>Taipei</city>
          <zip>112</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>CHIN-YU LIN</last_name>
        <phone>+886983215656</phone>
        <email>clouaa@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Taipei Veterans General Hospital, Taiwan</investigator_affiliation>
      <investigator_full_name>Chin-Yu Lin</investigator_full_name>
      <investigator_title>Doctor</investigator_title>
    </responsible_party>
    <keyword>persistent atrial fibrillation</keyword>
    <keyword>ablation</keyword>
    <keyword>driver</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Atrial Fibrillation</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06023888
  org study id: 2022-12-009C
  nct id: NCT06023888
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  STUDY DESIGN A prospective study.
  
        OBJECTIVE A single center clinical trial on the analysis of intracardiac atrial electrogram
        waveform periodicity for catheter ablation of persistent atrial fibrillation with OCTARAY™
        Mapping Catheter, as prospective randomized controlled study.
  
        HYPOTHESIS:
  
        The critical atrial substrates in maintaining persistent atrial fibrillation could be
        identified by non-linear electrogram morphology analysis in a point-by-point electroanatomic
        mapping. Based on the previous study, atrial substrate with high-similarity electrogram
        regions correlated with procedural AF termination and better long-term AF-free (1).
        Therefore, we proposed that the degree of waveform similarity plus the beat-to-beat
        sequential morphology (2) (duration of how many similar waveforms can maintain in sequence)
        would be even better to characterize the atrial substrate and could be potentially critical
        atrial substrate in prediction of sources of AF. As additional substrate mapping provided
        benefits compared to PVI alone in patients with persistent AF, we hypothesize that waveform
        periodicity adjuvant to electrogram similarity and phase mapping could be used to guide
        radiofrequency ablation in real time. The used of the OCTARAY™ Mapping Catheter could
        collected more AF electrogram and facilitate the mapping resolution and driver
        identification.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This study was designed to determine the efficacy of substrate ablation using waveform periodicity analysis, similarity analysis with OCTARAY™ Mapping Catheter could collected more AF electrogram and facilitate the mapping resolution and driver identification., plus phase mapping in persistent AF patients who required substrate modification.
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Recurrence of atrial arrhythmia
  time frame: up to 6 month
  description: atrial arrhythmia in 24-hour monitoring
  measure: Recurrence of atrial arrhythmia
  time frame: up to 1 year
  description: atrial arrhythmia in 7-day ECG monitoring
  arm group label: Periodicity-based
  arm group type: Experimental
  arm group label: Control
  arm group type: Other
  description: Standard ablation strategy as usual
  intervention type: Other
  intervention name: Mapping strategy
  description: The ablation strategy was based on the mapping results of periodicity.
  arm group label: Periodicity-based
  intervention type: Other
  intervention name: Mapping strategy
  description: PVI+ non-PV trigger
  arm group label: Control
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: CHIN-YU LIN, DR
  phone: +886983215656
  email: clouaa@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  responsible party type: Principal Investigator
  investigator affiliation: Taipei Veterans General Hospital, Taiwan
  investigator full name: Chin-Yu Lin
  investigator title: Doctor
  mesh term: Atrial Fibrillation