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/NCT05996159</url>
    </required_header>
    <id_info>
      <org_study_id>Q-INDEX</org_study_id>
      <nct_id>NCT05996159</nct_id>
    </id_info>
    <brief_title>Pulmonary Vein Isolation Strategy of Very High Power Short Duration in Patients With Paroxysmal Atrial Fibrillation</brief_title>
    <official_title>Pulmonary Vein Isolation Strategy of Very High Power Short Duration in Patients With Paroxysmal Atrial Fibrillation: Q-INDEX Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Seoul National University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Seoul National University Hospital</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 study aims to investigate the effect of reducing ablation time for a hybrid approach of&#xD;
        vHPSD and AI-guided ablation using the QDOT Micro catheter in PVI among patients with PAF.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Radiofrequency catheter ablation has become a cornerstone strategy for the rhythm control of&#xD;
        AF. During the last decade, catheter technology has revolutionized and, accordingly, clinical&#xD;
        outcomes after the ablation and procedural efficacy have been improved.&#xD;
  &#xD;
        In recent years, the use of the CLOSE protocol employing contiguous, closely spaced&#xD;
        applications and targeted ablation index (AI) values has translated into robust acute and&#xD;
        long-term success rates for PVI, typically with the power delivery of up to 35 W, and more&#xD;
        recently with 40 to 50 W, in power and temperature-controlled mode.&#xD;
  &#xD;
        Contiguous ablation using very high-power, short-duration ablation at 90 W over 4 seconds is&#xD;
        expected to shorten procedure time. However, changes in lesion geometry and the altered&#xD;
        impact of catheter stability on lesion quality may influence procedural efficiency, safety,&#xD;
        and effectiveness.&#xD;
  &#xD;
        The Q-FFICIENCY trial showed that the vHPSD (90 W, 4 sec), temperature-controlled&#xD;
        radiofrequency ablation (25/50 W) has comparable efficacy to conventional-power&#xD;
        temperature-controlled ablation.&#xD;
  &#xD;
        However, the efficacy of vHPSD ablation may depend on PV thickness due to its lesion&#xD;
        characteristics. Therefore, AI-guided ablation may have merits over vHPSD ablation in&#xD;
        thickened PV segments. According to the POWER PLUS trial, the proportion of 1st-pass PVI with&#xD;
        vHPSD ablation was numerically lower than that of the conventional ablation, although there&#xD;
        was marginal significance; 83.9% vs. 90.0%, p-value =0.085.&#xD;
  &#xD;
        According to the OPTIMUM trial, a study conducted by our group, roof and anterior walls of&#xD;
        the left atrium often require higher AI targets due to their thickness.&#xD;
  &#xD;
        Therefore, a hybrid approach that combines both vHPSD and AI-guided ablations according to PV&#xD;
        segments may achieve both high efficacy and short ablation time for PVI. The investigators of&#xD;
        the POWER PLUS trial also speculated that the hybrid approach based on tissue thickness might&#xD;
        offer the optimal balance of procedural efficacy.&#xD;
  &#xD;
        However, up to date, no studies have investigated the efficacy and safety of the hybrid&#xD;
        approach for PVI. More data is needed to suggest that the hybrid approach could be useful for&#xD;
        PVI.&#xD;
  &#xD;
        Therefore, this study aims to investigate the effect of reducing ablation time for a hybrid&#xD;
        approach of vHPSD and AI-guided ablation using the QDOT Micro catheter in PVI among patients&#xD;
        with PAF.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 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>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Time for AF ablation</measure>
      <time_frame>up to 12 months</time_frame>
      <description>Including total PVI time, total ablation time, fluoroscopic time, and total procedure time.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Acute PV reconnection rate</measure>
      <time_frame>up to 12 months</time_frame>
      <description>Including residual PV potential and early reconnection after 1st pass PVI.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The segment of residual PV potential</measure>
      <time_frame>up to 12 months</time_frame>
      <description>Descript as RSPV roof/anterior/posterior, RIPV anterior/posterior/inferior, Rt carina, LSPV roof/anterior(ridge)/posterior, LIPV anterior(ridge)/posterior/inferior, Lt carina.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The segment of early reconnection</measure>
      <time_frame>up to 12 months</time_frame>
      <description>Descript as RSPV roof/anterior/posterior, RIPV anterior/posterior/inferior, Rt carina, LSPV roof/anterior(ridge)/posterior, LIPV anterior(ridge)/posterior/inferior, Lt carina.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>1-year AF recurrence</measure>
      <time_frame>up to 12 months</time_frame>
      <description>Using single lead 3-day holter monitoring.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>30-day complication associated with procedure</measure>
      <time_frame>up to 12 months</time_frame>
      <description>Including puncture site hematoma, puncture site pseudoaneurysm, puncture site AV fistula, stroke, TIA, thromboembolism, and others.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Paroxysmal Atrial Fibrillation</condition>
    <arm_group>
      <arm_group_label>vHPSD ablation only for PVI</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Pulmonary vein encirclement is achieved using contiguous applications of very high power and short duration (90 W over 4 seconds). The inter-lesion distance is set at 3-4mm for the roofs and anterior segments, and 5-6mm for other segments. If the esophageal temperature rises &gt; 38 for segments near the esophagus, encirclement will be applied at 25 W for 15 seconds.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>vHPSD and AI-guided ablation for PVI</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>At the anterior segments, pulmonary vein encirclement is achieved through contiguous applications using AI-guided ablation (40-50 W, AI target 500, and an inter-lesion distance of 4mm).&#xD;
  In the other segments, pulmonary vein encirclement is achieved through contiguous applications using very high-power and short-duration techniques (90 W over 4 seconds, inter-lesion distance of 3-4mm; if the segments are near the esophagus, encirclement will be applied at 25 W for 15 seconds).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>AI-guided ablation only for PVI</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Pulmonary vein encirclement is achieved through contiguous applications using AI-guided ablation (40-50 W, AI target 500 for anterior segments and 400 for other segments, with an inter-lesion distance of 4mm; if the segments are near the esophagus, encirclement will be applied at 25 W for 15 seconds)</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>QDOT MicroTM catheter</intervention_name>
      <description>Novel high power-short duration ablation catheter for atrial fibrillation</description>
      <arm_group_label>vHPSD ablation only for PVI</arm_group_label>
      <arm_group_label>vHPSD and AI-guided ablation for PVI</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>AI-guided ablation only for PVI</intervention_name>
      <description>Ablation is the removal or destruction of something from an object by vaporization, chipping, erosive processes, or by other means.</description>
      <arm_group_label>AI-guided ablation only for PVI</arm_group_label>
      <arm_group_label>vHPSD and AI-guided ablation for PVI</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing PVI for PAF&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Aged less than 19 years&#xD;
  &#xD;
            -  Patients with persistent AF&#xD;
  &#xD;
            -  Patients with previous ablation or surgery for AF&#xD;
  &#xD;
            -  Patients with intracardiac thrombus or thromboembolic events within the previous 90&#xD;
               days&#xD;
  &#xD;
            -  Patients with cardiac surgery or acute coronary syndrome within the previous 90 days&#xD;
  &#xD;
            -  Patients with contraindication(s) for using oral anticoagulants&#xD;
  &#xD;
            -  Patients with LA anteroposterior diameter of more than 55 mm&#xD;
  &#xD;
            -  Patients with left ventricular ejection fraction less than 35%&#xD;
  &#xD;
            -  Pregnants or those who plan to become pregnant during the study&#xD;
  &#xD;
            -  Life expectancy less than a year&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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/NCT05996159
  org study id: Q-INDEX
  nct id: NCT05996159
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to investigate the effect of reducing ablation time for a hybrid approach of
        vHPSD and AI-guided ablation using the QDOT Micro catheter in PVI among patients with PAF.
  Radiofrequency catheter ablation has become a cornerstone strategy for the rhythm control of
        AF. During the last decade, catheter technology has revolutionized and, accordingly, clinical
        outcomes after the ablation and procedural efficacy have been improved.
  
        In recent years, the use of the CLOSE protocol employing contiguous, closely spaced
        applications and targeted ablation index (AI) values has translated into robust acute and
        long-term success rates for PVI, typically with the power delivery of up to 35 W, and more
        recently with 40 to 50 W, in power and temperature-controlled mode.
  
        Contiguous ablation using very high-power, short-duration ablation at 90 W over 4 seconds is
        expected to shorten procedure time. However, changes in lesion geometry and the altered
        impact of catheter stability on lesion quality may influence procedural efficiency, safety,
        and effectiveness.
  
        The Q-FFICIENCY trial showed that the vHPSD (90 W, 4 sec), temperature-controlled
        radiofrequency ablation (25/50 W) has comparable efficacy to conventional-power
        temperature-controlled ablation.
  
        However, the efficacy of vHPSD ablation may depend on PV thickness due to its lesion
        characteristics. Therefore, AI-guided ablation may have merits over vHPSD ablation in
        thickened PV segments. According to the POWER PLUS trial, the proportion of 1st-pass PVI with
        vHPSD ablation was numerically lower than that of the conventional ablation, although there
        was marginal significance; 83.9% vs. 90.0%, p-value =0.085.
  
        According to the OPTIMUM trial, a study conducted by our group, roof and anterior walls of
        the left atrium often require higher AI targets due to their thickness.
  
        Therefore, a hybrid approach that combines both vHPSD and AI-guided ablations according to PV
        segments may achieve both high efficacy and short ablation time for PVI. The investigators of
        the POWER PLUS trial also speculated that the hybrid approach based on tissue thickness might
        offer the optimal balance of procedural efficacy.
  
        However, up to date, no studies have investigated the efficacy and safety of the hybrid
        approach for PVI. More data is needed to suggest that the hybrid approach could be useful for
        PVI.
  
        Therefore, this study aims to investigate the effect of reducing ablation time for a hybrid
        approach of vHPSD and AI-guided ablation using the QDOT Micro catheter in PVI among patients
        with PAF.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Time for AF ablation
  time frame: up to 12 months
  description: Including total PVI time, total ablation time, fluoroscopic time, and total procedure time.
  measure: Acute PV reconnection rate
  time frame: up to 12 months
  description: Including residual PV potential and early reconnection after 1st pass PVI.
  measure: The segment of residual PV potential
  time frame: up to 12 months
  description: Descript as RSPV roof/anterior/posterior, RIPV anterior/posterior/inferior, Rt carina, LSPV roof/anterior(ridge)/posterior, LIPV anterior(ridge)/posterior/inferior, Lt carina.
  measure: The segment of early reconnection
  time frame: up to 12 months
  description: Descript as RSPV roof/anterior/posterior, RIPV anterior/posterior/inferior, Rt carina, LSPV roof/anterior(ridge)/posterior, LIPV anterior(ridge)/posterior/inferior, Lt carina.
  measure: 1-year AF recurrence
  time frame: up to 12 months
  description: Using single lead 3-day holter monitoring.
  measure: 30-day complication associated with procedure
  time frame: up to 12 months
  description: Including puncture site hematoma, puncture site pseudoaneurysm, puncture site AV fistula, stroke, TIA, thromboembolism, and others.
  arm group label: vHPSD ablation only for PVI
  arm group type: Experimental
  description: Pulmonary vein encirclement is achieved using contiguous applications of very high power and short duration (90 W over 4 seconds). The inter-lesion distance is set at 3-4mm for the roofs and anterior segments, and 5-6mm for other segments. If the esophageal temperature rises > 38 for segments near the esophagus, encirclement will be applied at 25 W for 15 seconds.
  arm group label: vHPSD and AI-guided ablation for PVI
  arm group type: Experimental
  description: At the anterior segments, pulmonary vein encirclement is achieved through contiguous applications using AI-guided ablation (40-50 W, AI target 500, and an inter-lesion distance of 4mm).
  In the other segments, pulmonary vein encirclement is achieved through contiguous applications using very high-power and short-duration techniques (90 W over 4 seconds, inter-lesion distance of 3-4mm; if the segments are near the esophagus, encirclement will be applied at 25 W for 15 seconds).
  arm group label: AI-guided ablation only for PVI
  arm group type: Experimental
  description: Pulmonary vein encirclement is achieved through contiguous applications using AI-guided ablation (40-50 W, AI target 500 for anterior segments and 400 for other segments, with an inter-lesion distance of 4mm; if the segments are near the esophagus, encirclement will be applied at 25 W for 15 seconds)
  intervention type: Device
  intervention name: QDOT MicroTM catheter
  description: Novel high power-short duration ablation catheter for atrial fibrillation
  arm group label: vHPSD ablation only for PVI
  arm group label: vHPSD and AI-guided ablation for PVI
  intervention type: Device
  intervention name: AI-guided ablation only for PVI
  description: Ablation is the removal or destruction of something from an object by vaporization, chipping, erosive processes, or by other means.
  arm group label: AI-guided ablation only for PVI
  arm group label: vHPSD and AI-guided ablation for PVI
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Atrial Fibrillation