<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/NCT03831516</url>
  </required_header>
  <id_info>
    <org_study_id>18-0364</org_study_id>
    <nct_id>NCT03831516</nct_id>
  </id_info>
  <brief_title>Non-Invasive 3D Mapping for Identifying Origin and Preferential Propagation of Ventricular Arrhythmias</brief_title>
  <official_title>Non-Invasive 3D Mapping for Identifying Origin and Preferential Propagation of Ventricular Arrhythmias</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwell Health</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_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will measure the diagnostic sensitivity and specificity of the Medtronic&#xD;
      CardioInsight wearable 252 electrode vest in predicting the chamber of origin of premature&#xD;
      ventricular complexes (PVCs) and compare its diagnostic accuracy with the standard 12- lead&#xD;
      ECG.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Until recently, the only non-invasive diagnostic modality to help identify the location of&#xD;
      ventricular arrhythmias was the 12 lead ECG. The Medtronic CardioInsight wearable vest is a&#xD;
      recently FDA approved diagnostic modality noninvasive, single beat cardiac mapping system&#xD;
      that provides 3D electroanatomic maps of the ventricular chambers. CardioInsight projects&#xD;
      unipolar signals collected from a 252-electrode vest to cardiac chambers imaged with a&#xD;
      non-contrast CT of the chest. The created non-invasive 3D electroanatomical maps can be&#xD;
      evaluated by the physicians pre-procedurally but also during the actual electrophysiology&#xD;
      study (EPS).&#xD;
&#xD;
      The technology has been approved by FDA for non-invasive mapping of any arrhythmias, however&#xD;
      there is little evidence on its value in predicting the origin of ventricular arrhythmias and&#xD;
      its proven diagnostic superiority over the standard 12-lead ECG.&#xD;
&#xD;
      With this study the investigators seek to assess the sensitivity and specificity of&#xD;
      CardioInsight in predicting the chamber of origin of ventricular arrhythmias and compare its&#xD;
      diagnostic accuracy with the standard 12-lead ECG. The study will include thirty patients&#xD;
      with ventricular arrhythmias undergoing EPS and ablation. The day of the procedure patients&#xD;
      will be fitted with the CardioInsight vest and undergo a non-contrast CT chest. Spontaneous&#xD;
      arrhythmias will be recorded and noninvasive 3D maps will be created prior and during the&#xD;
      EPS. The non-invasive maps will be used, per operator discretion, in designing mapping and&#xD;
      ablative strategies during the EPS. The true origin of the arrhythmia will be determined&#xD;
      during the EPS. In addition, the investigators will perform threshold pacing from common site&#xD;
      of idiopathic ventricular arrhythmias. The 12-lead ECGs and non-invasive maps will be stored&#xD;
      for off line review and analysis.&#xD;
&#xD;
      Non-invasive maps, as well as ECGs of spontaneous arrhythmias and pacemaps will be evaluated&#xD;
      off line by 2 electrophysiologists blinded to the results of the EPS. The sensitivity and&#xD;
      specificity of the 12 lead ECG, as well as the non-invasive maps, in predicting the site of&#xD;
      origin of the ventricular arrhythmias and pacemaps will be calculated and compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 4, 2019</start_date>
  <completion_date type="Actual">March 1, 2022</completion_date>
  <primary_completion_date type="Actual">March 1, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Predicting Origin</measure>
    <time_frame>12 month</time_frame>
    <description>Measure the diagnostic sensitivity and specificity of non-invasive mapping system in predicting origin of spontaneous ventricular arrhythmias in patients undergoing EPS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Preferential Electrical Propagation of Ventricular Arrhythmia</measure>
    <time_frame>12 month</time_frame>
    <description>Identify and describe the presence of preferential electrical propagation of ventricular arrhythmias in patients undergoing EPS.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Premature Ventricular Complex</condition>
  <condition>Ventricular Arrythmia</condition>
  <arm_group>
    <arm_group_label>Non Invasive Electroanatomical Mapping</arm_group_label>
    <description>Patients will undergo non invasive electroanatomical mapping (CardioInsight by Medtronic) prior and during an invasive electrophysiology study and ablation of ventricular Arrhythmias.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Non Invasive Electroanatomical Mapping</intervention_name>
    <description>All patients will undergo non contrast CT chest and be fitted with the Medtronic CardioInsight wearable 252 electrode vest. Non invasive electroanatomical maps of the ventricular arrhythmia will be created. All patients will be then brought to the electrophysiology laboratory and undergo an invasive electrophysiology study and ablation of the ventricular arrhythmia.</description>
    <arm_group_label>Non Invasive Electroanatomical Mapping</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with ventricular arrhythmias (premature ventricular complexes - PVC or ventricular&#xD;
        tachycardias - VT) requiring EPS for risk stratification or ablation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with PVCs or VT requiring EPS for:&#xD;
&#xD;
          -  Symptomatic arrhythmias&#xD;
&#xD;
          -  High PVC burden&#xD;
&#xD;
          -  Presence of cardiomyopathy&#xD;
&#xD;
          -  Risk stratification to determine which patients to offer ablative vs medical therapy&#xD;
             and for ICD implantation if deemed high risk for sudden cardiac death.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients in acute coronary syndrome&#xD;
&#xD;
          -  Patient with congestive heart failure in acute decompensation&#xD;
&#xD;
          -  Patients in rapid atrial fibrillation&#xD;
&#xD;
          -  Patients requiring persistent ventricular pacing&#xD;
&#xD;
          -  Patient who refuse to undergo EPS&#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>Stavros Mountantonakis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwell Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lenox Hill Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>April 18, 2022</last_update_submitted>
  <last_update_submitted_qc>April 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwell Health</investigator_affiliation>
    <investigator_full_name>Stavros E Mountantonakis</investigator_full_name>
    <investigator_title>Associate Director of Cardiac Electrophysiology</investigator_title>
  </responsible_party>
  <keyword>Ablation</keyword>
  <keyword>Ventricular Tachycardia</keyword>
  <keyword>Mapping</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
    <mesh_term>Ventricular Premature Complexes</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/NCT03831516
org study id: 18-0364
nct id: NCT03831516
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study will measure the diagnostic sensitivity and specificity of the Medtronic
      CardioInsight wearable 252 electrode vest in predicting the chamber of origin of premature
      ventricular complexes (PVCs) and compare its diagnostic accuracy with the standard 12- lead
      ECG.
Until recently, the only non-invasive diagnostic modality to help identify the location of
      ventricular arrhythmias was the 12 lead ECG. The Medtronic CardioInsight wearable vest is a
      recently FDA approved diagnostic modality noninvasive, single beat cardiac mapping system
      that provides 3D electroanatomic maps of the ventricular chambers. CardioInsight projects
      unipolar signals collected from a 252-electrode vest to cardiac chambers imaged with a
      non-contrast CT of the chest. The created non-invasive 3D electroanatomical maps can be
      evaluated by the physicians pre-procedurally but also during the actual electrophysiology
      study (EPS).

      The technology has been approved by FDA for non-invasive mapping of any arrhythmias, however
      there is little evidence on its value in predicting the origin of ventricular arrhythmias and
      its proven diagnostic superiority over the standard 12-lead ECG.

      With this study the investigators seek to assess the sensitivity and specificity of
      CardioInsight in predicting the chamber of origin of ventricular arrhythmias and compare its
      diagnostic accuracy with the standard 12-lead ECG. The study will include thirty patients
      with ventricular arrhythmias undergoing EPS and ablation. The day of the procedure patients
      will be fitted with the CardioInsight vest and undergo a non-contrast CT chest. Spontaneous
      arrhythmias will be recorded and noninvasive 3D maps will be created prior and during the
      EPS. The non-invasive maps will be used, per operator discretion, in designing mapping and
      ablative strategies during the EPS. The true origin of the arrhythmia will be determined
      during the EPS. In addition, the investigators will perform threshold pacing from common site
      of idiopathic ventricular arrhythmias. The 12-lead ECGs and non-invasive maps will be stored
      for off line review and analysis.

      Non-invasive maps, as well as ECGs of spontaneous arrhythmias and pacemaps will be evaluated
      off line by 2 electrophysiologists blinded to the results of the EPS. The sensitivity and
      specificity of the 12 lead ECG, as well as the non-invasive maps, in predicting the site of
      origin of the ventricular arrhythmias and pacemaps will be calculated and compared.
observational model: Cohort
time perspective: Prospective
measure: Predicting Origin
time frame: 12 month
description: Measure the diagnostic sensitivity and specificity of non-invasive mapping system in predicting origin of spontaneous ventricular arrhythmias in patients undergoing EPS
measure: Preferential Electrical Propagation of Ventricular Arrhythmia
time frame: 12 month
description: Identify and describe the presence of preferential electrical propagation of ventricular arrhythmias in patients undergoing EPS.
arm group label: Non Invasive Electroanatomical Mapping
description: Patients will undergo non invasive electroanatomical mapping (CardioInsight by Medtronic) prior and during an invasive electrophysiology study and ablation of ventricular Arrhythmias.
intervention type: Diagnostic Test
intervention name: Non Invasive Electroanatomical Mapping
description: All patients will undergo non contrast CT chest and be fitted with the Medtronic CardioInsight wearable 252 electrode vest. Non invasive electroanatomical maps of the ventricular arrhythmia will be created. All patients will be then brought to the electrophysiology laboratory and undergo an invasive electrophysiology study and ablation of the ventricular arrhythmia.
arm group label: Non Invasive Electroanatomical Mapping
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stavros Mountantonakis, MD
role: Principal Investigator
affiliation: Northwell Health
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwell Health
investigator full name: Stavros E Mountantonakis
investigator title: Associate Director of Cardiac Electrophysiology
mesh term: Arrhythmias, Cardiac
mesh term: Ventricular Premature Complexes
sharing ipd: No