<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/NCT04429464</url>
  </required_header>
  <id_info>
    <org_study_id>CLP-14</org_study_id>
    <nct_id>NCT04429464</nct_id>
  </id_info>
  <brief_title>AcQBlate Force Confirmatory Study for Atrial Arrhythmias</brief_title>
  <official_title>AcQBlate Force Confirmatory Study for Atrial Arrhythmias (AcQBlate Force-PRA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Acutus Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Acutus Medical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      AcQBlate Force Confirmatory Study for Atrial Arrhythmias (AcQBlate Force-PRA)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acutus Medical's AcQBlate Force Ablation Catheter when used in combination with the Qubic&#xD;
      Force Sensing Module (AcQBlate Force System), is indicated for cardiac electrophysiological&#xD;
      mapping, delivery of diagnostic pacing stimuli, and radiofrequency ablation of sustained or&#xD;
      recurrent atrial arrhythmias.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Due to restrictions related to COVID the sponsor has decided not to move forward with this&#xD;
    study&#xD;
  </why_stopped>
  <start_date type="Anticipated">October 1, 2020</start_date>
  <completion_date type="Anticipated">November 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 15, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>The patient population will consist of men and women between the ages of 18 - 80 years, presenting for a de novo or repeat left-sided atrial ablation for symptomatic paroxysmal atrial fibrillation (PAF) or persistent atrial fibrillation (PerAF).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Subjects that demonstrate electrical isolation of the intended ablation</measure>
    <time_frame>At the end of their ablation procedure</time_frame>
    <description>The Primary Endpoint for Performance is an analysis of the proportion of subjects that demonstrate electrical isolation (block) of the intended ablation targets.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of subjects who are free from device/procedure related Major Adverse Events</measure>
    <time_frame>Through 30-days post procedure</time_frame>
    <description>The Primary Endpoint for Safety is an analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the ablation procedure through 30-days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjects with freedom from an atrial arrhythmia</measure>
    <time_frame>30-days post index procedure</time_frame>
    <description>The Secondary Endpoint for Performance is documentation of subjects with freedom from an atrial arrhythmia at 30-days post index procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of all identified SAEs, SADEs, and UADEs.</measure>
    <time_frame>Through 30-days post procedure</time_frame>
    <description>The Secondary Endpoint for Safety is a recording and analysis of all identified serious adverse events (SAEs), serious adverse device effects (SADEs), and unanticipated adverse device effects (UADEs) through 30-days post-procedure.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Atrial Arrhythmias</condition>
  <arm_group>
    <arm_group_label>Non-randomized</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will be treated using the Acutus Medical's AcQBlate Force Sensing Ablation Catheter in combination with the Qubic Force Sensing Module (AcQBlate Force Sensing System) to treat their arrhythmia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AcQBlate Force Sensing Ablation Catheter</intervention_name>
    <description>Confirmation that the AcQBlate Force System is safe and effective for the treatment of atrial arrhythmias</description>
    <arm_group_label>Non-randomized</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female between the ages of 18 to 80 years at time of consent.&#xD;
&#xD;
          -  Clinically indicated and scheduled for a de novo or repeat catheter ablation of PAF or&#xD;
             PerAF&#xD;
&#xD;
          -  Willing and able to provide written informed consent to to participate in the study&#xD;
             and agree to comply with all follow-up visits and evaluations for the duration of the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  In the opinion of the investigator, any contraindication to the planned atrial&#xD;
             ablation, including anticoagulation contraindications or sepsis&#xD;
&#xD;
          -  Continuous AF &gt; 12-months (long-standing persistent AF)&#xD;
&#xD;
          -  Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other&#xD;
             reversible or non-cardiac cause.&#xD;
&#xD;
          -  An implanted pacemaker or Implantable Cardiac Defibrillator (ICD).&#xD;
&#xD;
          -  Structural heart disease or cardiac history as described below:&#xD;
&#xD;
          -  Left ventricular ejection fraction (LVEF) &lt; 35% based on transthoracic echocardiogram&#xD;
             (TTE) within the previous 180-days.&#xD;
&#xD;
          -  Left atrial size &gt; 55 mm based on TTE within the previous 180-days.&#xD;
&#xD;
          -  Evidence of heart failure (NYHA Class III or IV).&#xD;
&#xD;
          -  Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for&#xD;
             coronary artery bypass).&#xD;
&#xD;
          -  Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve.&#xD;
&#xD;
          -  Coronary artery bypass graft (CABG) or coronary angioplasty (PTCA) procedure within&#xD;
             the last 90-days.&#xD;
&#xD;
          -  Unstable angina or ongoing myocardial ischemia.&#xD;
&#xD;
          -  Severe uncontrolled systemic hypertension (systolic pressure &gt; 240 mm Hg, diastolic&#xD;
             pressure &gt; 140 mm Hg recorded within the last 30-days.&#xD;
&#xD;
          -  Moderate or severe tricuspid stenosis or regurgitation.&#xD;
&#xD;
          -  Moderate or severe mitral stenosis or regurgitation.&#xD;
&#xD;
          -  Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder.&#xD;
&#xD;
          -  Presence of a left atrial appendage occlusion device.&#xD;
&#xD;
          -  Previous PV stenting or evidence of PV stenosis&#xD;
&#xD;
          -  Body Mass Index (BMI) &gt;40 kg/m2&#xD;
&#xD;
          -  History of blood clotting or bleeding disease.&#xD;
&#xD;
          -  Any prior history of documented cerebral infarct or systemic embolism (excluding post-&#xD;
             operative deep vein thrombosis (DVT)).&#xD;
&#xD;
          -  Pregnant or lactating (current or anticipated during study follow up).&#xD;
&#xD;
          -  Current enrollment in any other study protocol where testing or results from the study&#xD;
             may interfere with the procedure or outcome measurements for this study.&#xD;
&#xD;
          -  Any other condition that, in the judgment of the investigator, makes the patient a&#xD;
             poor candidate for this procedure, the study or compliance with the protocol (includes&#xD;
             vulnerable patient population, mental illness, addictive disease, terminal illness&#xD;
             with a life expectancy of less than two years, extensive travel away from the research&#xD;
             center)&#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>Petr Neuzil, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Na Homolce Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Na Homolce Hospital</name>
      <address>
        <city>Prague</city>
        <zip>150 30</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>October 12, 2021</last_update_submitted>
  <last_update_submitted_qc>October 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ablation</keyword>
  <keyword>atrial arrhythmia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
  </condition_browse>
  <!-- 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/NCT04429464
org study id: CLP-14
nct id: NCT04429464
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
AcQBlate Force Confirmatory Study for Atrial Arrhythmias (AcQBlate Force-PRA)
Acutus Medical's AcQBlate Force Ablation Catheter when used in combination with the Qubic
      Force Sensing Module (AcQBlate Force System), is indicated for cardiac electrophysiological
      mapping, delivery of diagnostic pacing stimuli, and radiofrequency ablation of sustained or
      recurrent atrial arrhythmias.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The patient population will consist of men and women between the ages of 18 - 80 years, presenting for a de novo or repeat left-sided atrial ablation for symptomatic paroxysmal atrial fibrillation (PAF) or persistent atrial fibrillation (PerAF).
primary purpose: Treatment
masking: None (Open Label)
measure: Subjects that demonstrate electrical isolation of the intended ablation
time frame: At the end of their ablation procedure
description: The Primary Endpoint for Performance is an analysis of the proportion of subjects that demonstrate electrical isolation (block) of the intended ablation targets.
measure: Proportion of subjects who are free from device/procedure related Major Adverse Events
time frame: Through 30-days post procedure
description: The Primary Endpoint for Safety is an analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the ablation procedure through 30-days.
measure: Subjects with freedom from an atrial arrhythmia
time frame: 30-days post index procedure
description: The Secondary Endpoint for Performance is documentation of subjects with freedom from an atrial arrhythmia at 30-days post index procedure.
measure: Analysis of all identified SAEs, SADEs, and UADEs.
time frame: Through 30-days post procedure
description: The Secondary Endpoint for Safety is a recording and analysis of all identified serious adverse events (SAEs), serious adverse device effects (SADEs), and unanticipated adverse device effects (UADEs) through 30-days post-procedure.
arm group label: Non-randomized
arm group type: Experimental
description: All subjects will be treated using the Acutus Medical's AcQBlate Force Sensing Ablation Catheter in combination with the Qubic Force Sensing Module (AcQBlate Force Sensing System) to treat their arrhythmia.
intervention type: Device
intervention name: AcQBlate Force Sensing Ablation Catheter
description: Confirmation that the AcQBlate Force System is safe and effective for the treatment of atrial arrhythmias
arm group label: Non-randomized
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Petr Neuzil, MD
role: Principal Investigator
affiliation: Na Homolce Hospital
facility: 
country: Czechia
responsible party type: Sponsor
mesh term: Arrhythmias, Cardiac