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/NCT05989321</url>
    </required_header>
    <id_info>
      <org_study_id>IIT-2023-0052-XXG-004</org_study_id>
      <nct_id>NCT05989321</nct_id>
    </id_info>
    <brief_title>A New Approach for Catheter Ablation of Atrial Fibrillation</brief_title>
    <official_title>A New Approach for Catheter Ablation of Atrial Fibrillation: a Retrospective Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Second Affiliated Hospital of Kunming Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Second Affiliated Hospital of Kunming Medical University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a retrospective cohort study of radiofrequency ablation for the treatment atrial&#xD;
        fibrillation(AF). Based on the electrophysiological phenomena found in these cases, the&#xD;
        investigators propose a hypothesis regarding the underlying electrophysiological mechanism of&#xD;
        AF, as well as a novel approach for catheter ablation of AF.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators propose a new electrophysiological mechanism for AF: the superposition&#xD;
        hypothesis. The investigators tested this hypothesis by conducting the retrospective cohort&#xD;
        study to determine if superposition potentials (SP) can identify the critical regions where&#xD;
        AF is sustained and if ablating SPs can improves the long-term efﬁcacy.&#xD;
  &#xD;
        The study consecutively collected patients with underwent the first catheter ablation for&#xD;
        symptomatic AF in a university hospital from March 2021 to June 2022, including paroxysmal AF&#xD;
        (lasting &lt;7 days), persistent AF (lasting &gt;7 days and &lt;1 year without electrical&#xD;
        cardioversion) and long-term persistent AF (lasting &gt;1 year), aged between 18 and 80 years&#xD;
        old. AF recurrence was evaluated at 3, 6, 9, and 12 months using 72-hour Holter monitoring at&#xD;
        each clinic visit. The eligible patients were divided into two groups: the pulmonary vein&#xD;
        isolation(PVI) alone group (n=56) and the PVI + SPs ablation group(n=60).Comprehensive&#xD;
        clinical history and procedural data of patients were collected from electronic medical&#xD;
        records.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2021</start_date>
    <completion_date type="Actual">July 15, 2022</completion_date>
    <primary_completion_date type="Actual">June 30, 2022</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>freedom from AF within 12 months</measure>
      <time_frame>12 months</time_frame>
      <description>AF recurrence was evaluated at 3, 6, 9, and 12 months using 72-hour Holter monitoring at each clinic visit. AF recurrence was defined as the occurrence of AF lasting at least 30 seconds after the 3-month blanking period.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>the acute termination of AF during the procedure</measure>
      <time_frame>during the procedure</time_frame>
      <description>Conversion of AF to normal sinus rhythm or atrial tachyarrhythmias during ablation procedure.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">116</enrollment>
    <condition>Atrial Fibrillation</condition>
    <arm_group>
      <arm_group_label>PVI alone group</arm_group_label>
      <description>Patients who undergo PVI alone using ThermoCool SmartTouch catheter.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PVI + SPs ablation group</arm_group_label>
      <description>Patients who undergo PVI + SPs ablation using ThermoCool SmartTouch catheter.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>PVI alone</intervention_name>
      <description>pulmonary vein isolation</description>
      <arm_group_label>PVI alone group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>PVI + SPs ablation</intervention_name>
      <description>pulmonary vein isolation + SPs ablation</description>
      <arm_group_label>PVI + SPs ablation group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          These cases are from a university hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients with underwent the first catheter ablation for symptomatic AF&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients with more than one missing follow-up would be excluded&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mingli Zhou, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Second Affiliated Hospital of Kunming Medical University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Kunming Medical University</name>
        <address>
          <city>Kunming</city>
          <state>Yunnan</state>
          <zip>650000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <results_reference>
      <citation>Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available. Erratum In: Eur Heart J. 2021 Feb 1;42(5):507. Eur Heart J. 2021 Feb 1;42(5):546-547. Eur Heart J. 2021 Oct 21;42(40):4194.</citation>
      <PMID>32860505</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The Second Affiliated Hospital of Kunming Medical University</investigator_affiliation>
      <investigator_full_name>mingli Zhou</investigator_full_name>
      <investigator_title>associate chief physician</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Atrial Fibrillation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05989321
  org study id: IIT-2023-0052-XXG-004
  nct id: NCT05989321
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is a retrospective cohort study of radiofrequency ablation for the treatment atrial
        fibrillation(AF). Based on the electrophysiological phenomena found in these cases, the
        investigators propose a hypothesis regarding the underlying electrophysiological mechanism of
        AF, as well as a novel approach for catheter ablation of AF.
  The investigators propose a new electrophysiological mechanism for AF: the superposition
        hypothesis. The investigators tested this hypothesis by conducting the retrospective cohort
        study to determine if superposition potentials (SP) can identify the critical regions where
        AF is sustained and if ablating SPs can improves the long-term efﬁcacy.
  
        The study consecutively collected patients with underwent the first catheter ablation for
        symptomatic AF in a university hospital from March 2021 to June 2022, including paroxysmal AF
        (lasting <7 days), persistent AF (lasting >7 days and <1 year without electrical
        cardioversion) and long-term persistent AF (lasting >1 year), aged between 18 and 80 years
        old. AF recurrence was evaluated at 3, 6, 9, and 12 months using 72-hour Holter monitoring at
        each clinic visit. The eligible patients were divided into two groups: the pulmonary vein
        isolation(PVI) alone group (n=56) and the PVI + SPs ablation group(n=60).Comprehensive
        clinical history and procedural data of patients were collected from electronic medical
        records.
  observational model: Cohort
  time perspective: Retrospective
  measure: freedom from AF within 12 months
  time frame: 12 months
  description: AF recurrence was evaluated at 3, 6, 9, and 12 months using 72-hour Holter monitoring at each clinic visit. AF recurrence was defined as the occurrence of AF lasting at least 30 seconds after the 3-month blanking period.
  measure: the acute termination of AF during the procedure
  time frame: during the procedure
  description: Conversion of AF to normal sinus rhythm or atrial tachyarrhythmias during ablation procedure.
  arm group label: PVI alone group
  description: Patients who undergo PVI alone using ThermoCool SmartTouch catheter.
  arm group label: PVI + SPs ablation group
  description: Patients who undergo PVI + SPs ablation using ThermoCool SmartTouch catheter.
  intervention type: Procedure
  intervention name: PVI alone
  description: pulmonary vein isolation
  arm group label: PVI alone group
  intervention type: Procedure
  intervention name: PVI + SPs ablation
  description: pulmonary vein isolation + SPs ablation
  arm group label: PVI + SPs ablation group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Mingli Zhou, M.D.
  role: Principal Investigator
  affiliation: The Second Affiliated Hospital of Kunming Medical University
  facility: 
  country: China
  citation: Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available. Erratum In: Eur Heart J. 2021 Feb 1;42(5):507. Eur Heart J. 2021 Feb 1;42(5):546-547. Eur Heart J. 2021 Oct 21;42(40):4194.
  PMID: 32860505
  responsible party type: Principal Investigator
  investigator affiliation: The Second Affiliated Hospital of Kunming Medical University
  investigator full name: mingli Zhou
  investigator title: associate chief physician
  mesh term: Atrial Fibrillation
  sharing ipd: No