<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/NCT04447300</url>
  </required_header>
  <id_info>
    <org_study_id>atrial fibrillation ablation</org_study_id>
    <nct_id>NCT04447300</nct_id>
  </id_info>
  <brief_title>Outcomes of High Power Application in Catheter Ablation of Paroxysmal Atrial Fibrillation Guided by Unipolar Signal Modification.</brief_title>
  <official_title>Outcomes of High Power Application in Catheter Ablation of Paroxysmal Atrial Fibrillation Guided by Unipolar Signal Modification.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</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>
      Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation procedures in patients&#xD;
      with paroxysmal atrial fibrillation (PAF) [1]. However, the incidence of atrial fibrillation&#xD;
      (AF) recurrence remains high [2], mostly due to pulmonary vein (PV) reconnection [1],&#xD;
      emphasizing the formation of transmural lesions to achieve complete conduction block along&#xD;
      the ablation lines [3].&#xD;
&#xD;
      Previous studies have shown that elimination of the negative component of the unipolar&#xD;
      electrogram (UP-EGM) during radiofrequency applications reflects transmural lesions. The&#xD;
      persistence of such a negative component consistently corresponds to non-trans mural lesions&#xD;
      [4].&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation procedures in patients&#xD;
      with paroxysmal atrial fibrillation (PAF) [1]. However, the incidence of atrial fibrillation&#xD;
      (AF) recurrence remains high [2], mostly due to pulmonary vein (PV) reconnection [1],&#xD;
      emphasizing the formation of transmural lesions to achieve complete conduction block along&#xD;
      the ablation lines [3].&#xD;
&#xD;
      Previous studies have shown that elimination of the negative component of the unipolar&#xD;
      electrogram (UP-EGM) during radiofrequency applications reflects transmural lesions. The&#xD;
      persistence of such a negative component consistently corresponds to non-trans mural lesions&#xD;
      [4].&#xD;
&#xD;
      The high-power short duration (HPSD) RF application applies to all RF energies delivered at&#xD;
      more than 40 W [5]. Higher the power more is the resistive heating causing wider tissue&#xD;
      injury [5]. The lesion size with HPSD is larger in width but lesser in depth compared to&#xD;
      lower powers with longer duration [5]. In contrast, RF applications of lower power and longer&#xD;
      duration result in larger dissipation of RF energies deep into the tissues due to conductive&#xD;
      heating causing tissue destruction at greater depths [6]. Hence, there is a risk of&#xD;
      collateral tissue damage [5].&#xD;
&#xD;
      HPSD ablation has been advocated as a means to minimize the risk of collateral organ damage&#xD;
      as the lesions are smaller in depth. However, Maintaining a high power for a constant&#xD;
      duration in the absence of a guide may not be the right strategy [5].&#xD;
&#xD;
      Unipolar waveform modification by complete elimination of the negative component may serve as&#xD;
      a guide for HPSD ablation [5].&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 20, 2021</start_date>
  <completion_date type="Anticipated">March 20, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2022</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ablation success at 6-month after the index procedure</measure>
    <time_frame>6 months</time_frame>
    <description>Ablation success is defined as no recurrence with no anti-arrhythmic drugs by taking history of symptoms from the patient and by Holter 48 Hours.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Atrial Fibrillation Paroxysmal</condition>
  <arm_group>
    <arm_group_label>Standard power application</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>High power application</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>high power application</intervention_name>
    <description>Radiofrequency delivery was performed in a point-by point fashion and continuously (an inter-lesion distance of 6 mm) with 50 W and 70 W and the ablation time for each point is limited to 7s and repeated if needed till the Unipolar signal modification turn to complete positive R wave.</description>
    <arm_group_label>High power application</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard power application</intervention_name>
    <description>Standard power application</description>
    <arm_group_label>Standard power application</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Paroxysmal atrial fibrillation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age&lt; 18 or &gt; 80 years old,&#xD;
&#xD;
          -  Atrium (LA) diameter &gt; 50 mm,&#xD;
&#xD;
          -  The presence of a mechanical mitral valve prosthesis,&#xD;
&#xD;
          -  Left ventricular ejection fraction &lt; 40%,&#xD;
&#xD;
          -  Abnormal thyroid function,&#xD;
&#xD;
          -  Contraindication to anticoagulant therapy,&#xD;
&#xD;
          -  Current malignancy,&#xD;
&#xD;
          -  Prior catheter or surgical AF ablation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>Kottmaier M, Popa M, Bourier F, Reents T, Cifuentes J, Semmler V, Telishevska M, Otgonbayar U, Koch-Buttner K, Lennerz C, Bartkowiak M, Kornmayer M, Rousseva E, Brkic A, Grebmer C, Kolb C, Hessling G, Deisenhofer I. Safety and outcome of very high-power short-duration ablation using 70 W for pulmonary vein isolation in patients with paroxysmal atrial fibrillation. Europace. 2020 Mar 1;22(3):388-393. doi: 10.1093/europace/euz342.</citation>
    <PMID>31872249</PMID>
  </results_reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>January 12, 2021</last_update_submitted>
  <last_update_submitted_qc>January 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ahmad Abdelrady Abdelsalam Farghaly</investigator_full_name>
    <investigator_title>Assistant lecturer of cardiovascular medicine</investigator_title>
  </responsible_party>
  <keyword>Atrial fibrillation ablation - unipolar signal modification</keyword>
  <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>Undecided</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/NCT04447300
org study id: atrial fibrillation ablation
nct id: NCT04447300
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation procedures in patients
      with paroxysmal atrial fibrillation (PAF) [1]. However, the incidence of atrial fibrillation
      (AF) recurrence remains high [2], mostly due to pulmonary vein (PV) reconnection [1],
      emphasizing the formation of transmural lesions to achieve complete conduction block along
      the ablation lines [3].

      Previous studies have shown that elimination of the negative component of the unipolar
      electrogram (UP-EGM) during radiofrequency applications reflects transmural lesions. The
      persistence of such a negative component consistently corresponds to non-trans mural lesions
      [4].
Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation procedures in patients
      with paroxysmal atrial fibrillation (PAF) [1]. However, the incidence of atrial fibrillation
      (AF) recurrence remains high [2], mostly due to pulmonary vein (PV) reconnection [1],
      emphasizing the formation of transmural lesions to achieve complete conduction block along
      the ablation lines [3].

      Previous studies have shown that elimination of the negative component of the unipolar
      electrogram (UP-EGM) during radiofrequency applications reflects transmural lesions. The
      persistence of such a negative component consistently corresponds to non-trans mural lesions
      [4].

      The high-power short duration (HPSD) RF application applies to all RF energies delivered at
      more than 40 W [5]. Higher the power more is the resistive heating causing wider tissue
      injury [5]. The lesion size with HPSD is larger in width but lesser in depth compared to
      lower powers with longer duration [5]. In contrast, RF applications of lower power and longer
      duration result in larger dissipation of RF energies deep into the tissues due to conductive
      heating causing tissue destruction at greater depths [6]. Hence, there is a risk of
      collateral tissue damage [5].

      HPSD ablation has been advocated as a means to minimize the risk of collateral organ damage
      as the lesions are smaller in depth. However, Maintaining a high power for a constant
      duration in the absence of a guide may not be the right strategy [5].

      Unipolar waveform modification by complete elimination of the negative component may serve as
      a guide for HPSD ablation [5].
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Ablation success at 6-month after the index procedure
time frame: 6 months
description: Ablation success is defined as no recurrence with no anti-arrhythmic drugs by taking history of symptoms from the patient and by Holter 48 Hours.
arm group label: Standard power application
arm group type: Active Comparator
arm group label: High power application
arm group type: Active Comparator
intervention type: Procedure
intervention name: high power application
description: Radiofrequency delivery was performed in a point-by point fashion and continuously (an inter-lesion distance of 6 mm) with 50 W and 70 W and the ablation time for each point is limited to 7s and repeated if needed till the Unipolar signal modification turn to complete positive R wave.
arm group label: High power application
intervention type: Procedure
intervention name: Standard power application
description: Standard power application
arm group label: Standard power application
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
citation: Kottmaier M, Popa M, Bourier F, Reents T, Cifuentes J, Semmler V, Telishevska M, Otgonbayar U, Koch-Buttner K, Lennerz C, Bartkowiak M, Kornmayer M, Rousseva E, Brkic A, Grebmer C, Kolb C, Hessling G, Deisenhofer I. Safety and outcome of very high-power short-duration ablation using 70 W for pulmonary vein isolation in patients with paroxysmal atrial fibrillation. Europace. 2020 Mar 1;22(3):388-393. doi: 10.1093/europace/euz342.
PMID: 31872249
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ahmad Abdelrady Abdelsalam Farghaly
investigator title: Assistant lecturer of cardiovascular medicine
mesh term: Atrial Fibrillation
sharing ipd: Undecided