<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/NCT04473963</url>
  </required_header>
  <id_info>
    <org_study_id>CP-001/002</org_study_id>
    <nct_id>NCT04473963</nct_id>
  </id_info>
  <brief_title>FLOW-AF: A Study to Evaluate the Ablacon Electrographic FLOW EGF Technology</brief_title>
  <acronym>FLOW-AF</acronym>
  <official_title>A Randomized Controlled Study to Evaluate the Reliability of the Ablacon Electrographic FLOW (EGF) Algorithm Technology (Ablamap Software) to Identify AF Sources and Guide Ablation Therapy in Patients With Persistent Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ablacon, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ablacon, Inc.</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>
      This study is to evaluate the Ablacon Electrographic Flow (EGF) algorithm technology (Ablamap&#xD;
      Software).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to evaluate the reliability of the Ablacon Electrographic Flow&#xD;
      (EGF) algorithm technology (Ablamap Software) to identify atrial fibrillation sources and&#xD;
      guide ablation therapy in patients with persistent atrial fibrillation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 27, 2019</start_date>
  <completion_date type="Anticipated">November 29, 2022</completion_date>
  <primary_completion_date type="Actual">November 29, 2021</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Efficacy Endpoint: the ability to successfully ablate AF sources identified by the EGF algorithm as measured by EGF maps of the atria pre and post ablation to determine if there is a diminished or absence of the source.</measure>
    <time_frame>During the Procedure</time_frame>
    <description>Acute procedure success defined as the ability to successfully ablate AF sources identified by the EGF algorithm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Safety Endpoint: Freedom from serious adverse events</measure>
    <time_frame>7 days</time_frame>
    <description>Freedom from serious adverse events related to the procedure through 7 days following the randomization procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary Efficacy Endpoints: Consistency of sources</measure>
    <time_frame>Post procedure through 12 months</time_frame>
    <description>Consistency of sources identified by the Ablacon EGF algorithm between the randomization procedure and any applicable subsequent EGF-guided ablation procedures as assessed by remapping of the atria and the algorithm's ability to reproduce sources identified by a previous procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Efficacy Endpoints: Freedom from documented episodes of AF recurrence</measure>
    <time_frame>3-12 months</time_frame>
    <description>Freedom from documented episodes of atrial fibrillation recurrence following the blanking period (90 days post procedure through 12 months). Documentation will be from Holter recordings or EKGs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Efficacy Endpoints: Total number of EGF source ablations</measure>
    <time_frame>During the procedure</time_frame>
    <description>Total number of EGF source ablations (count number of ablations during the procedure)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Efficacy Endpoints: Total time of EGF source ablations</measure>
    <time_frame>During the procedure</time_frame>
    <description>Total time of EGF source ablations (seconds)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Efficacy Endpoints</measure>
    <time_frame>During the procedure</time_frame>
    <description>Total fluoroscopy time (min/sec)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Efficacy Endpoints</measure>
    <time_frame>During the procedure</time_frame>
    <description>Total fluoroscopy dose (mgy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Efficacy Endpoints: Overall Procedure time</measure>
    <time_frame>During the procedure</time_frame>
    <description>Overall Procedure time (hours/minutes)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Atrial Fibrillation, Persistent</condition>
  <arm_group>
    <arm_group_label>EGF-Guided Ablation Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects randomized to &quot;therapy&quot; will be treated with cardiac ablation guided by the Ablacon Electrographic flow algorithm technology (Ablamap Software).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control - No Ablation Therapy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects randomized to &quot;control&quot; will not be treated with cardiac ablation guided by the Ablacon Electrographic flow algorithm technology (Ablamap Software). The subjects will be cardioverted (as applicable) and the procedure will end.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ablamap Software</intervention_name>
    <description>Subjects will receive cardiac ablation guided by the Ablamap software. The software will identify atrial fibrillation sources to help guide ablation therapy in patients with persistent atrial fibrillation. Subjects will undergo a cardioversion post ablation, as necessary.</description>
    <arm_group_label>EGF-Guided Ablation Therapy</arm_group_label>
    <other_name>Ablamap Electrographic Flow Algorithm Technology</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Suitable candidate for intra-cardiac mapping and ablation of atrial arrhythmias.&#xD;
&#xD;
          2. Above eighteen (18) years of age or of legal age to give informed consent specific to&#xD;
             state and national law.&#xD;
&#xD;
          3. Subjects with a history of documented symptomatic, persistent or longstanding&#xD;
             persistent atrial fibrillation &lt; 36 months.&#xD;
&#xD;
          4. Subject agrees to comply with study procedures and be available (geographically&#xD;
             stable) for follow-up visits for at least 12 months.&#xD;
&#xD;
          5. Treatment of atrial fibrillation with ablation therapy presenting with recurrent&#xD;
             symptoms of AF (not applicable to De Novo subjects)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. LA diameter &gt; 5.5 cm.&#xD;
&#xD;
          2. Left ventricular ejection fraction (LVEF) &lt; 35%.&#xD;
&#xD;
          3. Presence of intramural thrombus, tumor or abnormality that precludes vascular access,&#xD;
             catheter introduction or manipulation.&#xD;
&#xD;
          4. Coagulopathy, bleeding diathesis or suspected procoagulant state.&#xD;
&#xD;
          5. Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used&#xD;
             in conjunction with the study or contrast sensitivity that cannot be adequately&#xD;
             pre-treated prior to the ablation procedure.&#xD;
&#xD;
          6. Positive pregnancy test results for female patients of childbearing potential or&#xD;
             breast feeding.&#xD;
&#xD;
          7. Acute or chronic medical condition that in the judgment of the investigator would&#xD;
             increase risk to the patient or deem the patient inappropriate to participate in the&#xD;
             study.&#xD;
&#xD;
          8. Mitral valve stenosis and/or severe mitral regurgitation.&#xD;
&#xD;
          9. Valvular atrial fibrillation.&#xD;
&#xD;
         10. Prosthetic valves.&#xD;
&#xD;
         11. NYHA Class IV.&#xD;
&#xD;
         12. History of MI within 3 months prior to procedure.&#xD;
&#xD;
         13. Atrial septal defect (ASD) or left atrial appendage (LAA) closure device.&#xD;
&#xD;
         14. Atrial fibrillation from a reversible cause (e.g., surgery, hyperthyroidism,&#xD;
             sarcoidosis or pericarditis).&#xD;
&#xD;
         15. Life expectancy &lt; 12 months based on medical history or the medical judgement of the&#xD;
             investigator.&#xD;
&#xD;
         16. Presence of any transvenous pacing, Implantable cardioverter defibrillators (ICD),&#xD;
             cardiac resynchronization therapy (CRT) leads.&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Petr Neuzil, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Principal Investigator - Czech Republic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tamas Szili-Torok, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Principal Investigator - The Netherlands</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stefan Spitzer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Principal Investigator - Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nemocnice Na Homolce Hospital</name>
      <address>
        <city>Prague</city>
        <state>Czech Republic</state>
        <zip>150 30</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>March 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>February 2, 2022</last_update_submitted>
  <last_update_submitted_qc>February 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2022</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>
  <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/NCT04473963
org study id: CP-001/002
nct id: NCT04473963
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is to evaluate the Ablacon Electrographic Flow (EGF) algorithm technology (Ablamap
      Software).
The objective of this study is to evaluate the reliability of the Ablacon Electrographic Flow
      (EGF) algorithm technology (Ablamap Software) to identify atrial fibrillation sources and
      guide ablation therapy in patients with persistent atrial fibrillation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary Efficacy Endpoint: the ability to successfully ablate AF sources identified by the EGF algorithm as measured by EGF maps of the atria pre and post ablation to determine if there is a diminished or absence of the source.
time frame: During the Procedure
description: Acute procedure success defined as the ability to successfully ablate AF sources identified by the EGF algorithm
measure: Primary Safety Endpoint: Freedom from serious adverse events
time frame: 7 days
description: Freedom from serious adverse events related to the procedure through 7 days following the randomization procedure.
measure: Secondary Efficacy Endpoints: Consistency of sources
time frame: Post procedure through 12 months
description: Consistency of sources identified by the Ablacon EGF algorithm between the randomization procedure and any applicable subsequent EGF-guided ablation procedures as assessed by remapping of the atria and the algorithm's ability to reproduce sources identified by a previous procedure
measure: Secondary Efficacy Endpoints: Freedom from documented episodes of AF recurrence
time frame: 3-12 months
description: Freedom from documented episodes of atrial fibrillation recurrence following the blanking period (90 days post procedure through 12 months). Documentation will be from Holter recordings or EKGs.
measure: Secondary Efficacy Endpoints: Total number of EGF source ablations
time frame: During the procedure
description: Total number of EGF source ablations (count number of ablations during the procedure)
measure: Secondary Efficacy Endpoints: Total time of EGF source ablations
time frame: During the procedure
description: Total time of EGF source ablations (seconds)
measure: Secondary Efficacy Endpoints
time frame: During the procedure
description: Total fluoroscopy time (min/sec)
measure: Secondary Efficacy Endpoints
time frame: During the procedure
description: Total fluoroscopy dose (mgy)
measure: Secondary Efficacy Endpoints: Overall Procedure time
time frame: During the procedure
description: Overall Procedure time (hours/minutes)
arm group label: EGF-Guided Ablation Therapy
arm group type: Experimental
description: Subjects randomized to "therapy" will be treated with cardiac ablation guided by the Ablacon Electrographic flow algorithm technology (Ablamap Software).
arm group label: Control - No Ablation Therapy
arm group type: No Intervention
description: Subjects randomized to "control" will not be treated with cardiac ablation guided by the Ablacon Electrographic flow algorithm technology (Ablamap Software). The subjects will be cardioverted (as applicable) and the procedure will end.
intervention type: Device
intervention name: Ablamap Software
description: Subjects will receive cardiac ablation guided by the Ablamap software. The software will identify atrial fibrillation sources to help guide ablation therapy in patients with persistent atrial fibrillation. Subjects will undergo a cardioversion post ablation, as necessary.
arm group label: EGF-Guided Ablation Therapy
other name: Ablamap Electrographic Flow Algorithm Technology
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Petr Neuzil, MD
role: Principal Investigator
affiliation: Principal Investigator - Czech Republic
last name: Tamas Szili-Torok, MD
role: Principal Investigator
affiliation: Principal Investigator - The Netherlands
last name: Stefan Spitzer, MD
role: Principal Investigator
affiliation: Principal Investigator - Germany
facility: 
country: Czechia
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: No