<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/NCT04477499</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 20-470</org_study_id>
    <nct_id>NCT04477499</nct_id>
  </id_info>
  <brief_title>Parallel Mapping for Ventricular Tachycardia</brief_title>
  <official_title>Ablation of Ventricular Tachycardia Guided by Multi-site Pacing Using Parallel Mapping</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biosense Webster, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The Cleveland Clinic</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>
      Catheter ablation in patients with ventricular tachycardia using a new mapping algorithm&#xD;
      called, parallel mapping, that is aimed to increase the specificity of mapping and the&#xD;
      outcome of ablation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In patients with scar in the hearts after heart attacks, the risk for dangerous abnormal&#xD;
      heart rhythms, including sudden death is high. This is because dead muscle fibers are&#xD;
      replaced by scar tissue, creating a physiological condition promoting abnormal heart&#xD;
      rhythms.These abnormal heart rhythms are called ventricular arrhythmias or ventricular&#xD;
      tachycardias. In these patients, ablation procedures can be helpful, however the recurrence&#xD;
      rate of arrhythmias after ablation remains unacceptably high. The primary reason for this&#xD;
      high recurrence rate is nonspecific mapping methodologies for identifying the heart area&#xD;
      responsible for these arrhythmias. Therefore, new methods for increasing the specificity of&#xD;
      mapping have been the subject of significant research for many years, however implementation&#xD;
      of these methods in clinical practice has been challenged by limited technologies. Recently,&#xD;
      a new mapping technology named &quot;parallel mapping&quot; has been developed, received FDA approval&#xD;
      and is routinely utilized at the Cleveland Clinic. However, the workflow of using parallel&#xD;
      mapping, and the efficacy of ablation using this technology have not been evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">December 30, 2022</completion_date>
  <primary_completion_date type="Actual">December 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Single procedure freedom from ventricular recurrence at 1 year</measure>
    <time_frame>12 months</time_frame>
    <description>Number of VT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Freedom from implantable cardioverter defibrillator (ICD) shocks</measure>
    <time_frame>12 months</time_frame>
    <description>Number of ICD shocks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in mapping time using parallel mapping algorithm</measure>
    <time_frame>12 months</time_frame>
    <description>Minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in radiofrequency ablation time</measure>
    <time_frame>12 months</time_frame>
    <description>Minutes</description>
  </secondary_outcome>
  <enrollment type="Actual">44</enrollment>
  <condition>Ventricular Tachycardia (V-Tach)</condition>
  <condition>Implantable Cardioverter Defibrillator (ICD)</condition>
  <condition>Arrythmia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with history of scar-mediated recurrent ventricular tachycardia, who had failed&#xD;
        therapy with anti arrhythmic drugs. All patients are planned to undergo catheter ablation&#xD;
        procedure for ventricular tachycardia as part of the usual clinical care. All patients who&#xD;
        meet the eligibility criteria may be included in the study regardless of gender, race or&#xD;
        ethnicity.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  History of scar-mediated sustained ventricular tachycardia&#xD;
&#xD;
          -  Failure of therapy with Anti arrhythmic drugs&#xD;
&#xD;
          -  Implanted ICD or a plan for ICD implantation after the ablation&#xD;
&#xD;
          -  Willingness to adhere to the study restrictions and comply with all post procedural&#xD;
             follow-up requirements&#xD;
&#xD;
          -  Ability to understand the requirements of the study and sign an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with reversible causes of ventricular tachycardia including ongoing ischemia&#xD;
             or electrolyte abnormalities&#xD;
&#xD;
          -  Contraindication to anticoagulation therapy&#xD;
&#xD;
          -  Stroke within 30 days before enrollment&#xD;
&#xD;
          -  Life expectancy &lt;1 year&#xD;
&#xD;
          -  Individual has a known, unresolved history of drug use or alcohol dependency lacks the&#xD;
             ability to comprehend or follow instructions or would be unlikely or unable to comply&#xD;
             with study follow-up requirements&#xD;
&#xD;
          -  Pregnant or breast feeding at time of signing consent&#xD;
&#xD;
          -  Patient undergoing cardiac transplantation&#xD;
&#xD;
          -  Enrolled or participates in other drug or device studies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jakub Sroubek, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>January 9, 2023</last_update_submitted>
  <last_update_submitted_qc>January 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Jakub Sroubek</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tachycardia</mesh_term>
    <mesh_term>Tachycardia, Ventricular</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/NCT04477499
org study id: IRB 20-470
nct id: NCT04477499
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Catheter ablation in patients with ventricular tachycardia using a new mapping algorithm
      called, parallel mapping, that is aimed to increase the specificity of mapping and the
      outcome of ablation.
In patients with scar in the hearts after heart attacks, the risk for dangerous abnormal
      heart rhythms, including sudden death is high. This is because dead muscle fibers are
      replaced by scar tissue, creating a physiological condition promoting abnormal heart
      rhythms.These abnormal heart rhythms are called ventricular arrhythmias or ventricular
      tachycardias. In these patients, ablation procedures can be helpful, however the recurrence
      rate of arrhythmias after ablation remains unacceptably high. The primary reason for this
      high recurrence rate is nonspecific mapping methodologies for identifying the heart area
      responsible for these arrhythmias. Therefore, new methods for increasing the specificity of
      mapping have been the subject of significant research for many years, however implementation
      of these methods in clinical practice has been challenged by limited technologies. Recently,
      a new mapping technology named "parallel mapping" has been developed, received FDA approval
      and is routinely utilized at the Cleveland Clinic. However, the workflow of using parallel
      mapping, and the efficacy of ablation using this technology have not been evaluated.
observational model: Other
time perspective: Prospective
measure: Single procedure freedom from ventricular recurrence at 1 year
time frame: 12 months
description: Number of VT
measure: Freedom from implantable cardioverter defibrillator (ICD) shocks
time frame: 12 months
description: Number of ICD shocks
measure: Reduction in mapping time using parallel mapping algorithm
time frame: 12 months
description: Minutes
measure: Reduction in radiofrequency ablation time
time frame: 12 months
description: Minutes
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jakub Sroubek, MD, PhD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Jakub Sroubek
investigator title: Principal Investigator
mesh term: Tachycardia
mesh term: Tachycardia, Ventricular
sharing ipd: No