<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/NCT02994446</url>
  </required_header>
  <id_info>
    <org_study_id>RD-14-001P</org_study_id>
    <nct_id>NCT02994446</nct_id>
  </id_info>
  <brief_title>Saline-Enhanced Radiofrequency (SERF) Catheter Ablation for the Treatment of Ventricular Tachycardia</brief_title>
  <acronym>SERF-VT</acronym>
  <official_title>Saline-Enhanced Radiofrequency (SERF) Catheter Ablation for the Treatment of Ventricular Tachycardia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thermedical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Thermedical, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to demonstrate the technical feasibility of the SERF Catheter&#xD;
      and SERF Cardiac Ablation System to eliminate or control ventricular tachycardia (VT)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">October 4, 2021</completion_date>
  <primary_completion_date type="Actual">April 21, 2021</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serious Adverse Events that are potentially device-related</measure>
    <time_frame>Within 30 days of ablation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Major Adverse Cardiac Events</measure>
    <time_frame>Within 2 days after ablation procedure</time_frame>
    <description>MACE will be accessed from time of ablation to time of discharge from hospital following the ablation (generally within 2 days of ablation procedure).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-inducibility of clinical ventricular tachycardia (VT) and/or elimination of clinically relevant scar or channels</measure>
    <time_frame>At completion of ablation procedure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intraprocedural non-inducibility and/or scar homogenization of target VT</measure>
    <time_frame>At completion of ablation procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elimination of the target VT and/or reduction in number of VT episodes</measure>
    <time_frame>Within first 6 months of ablation procedure</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Tachycardia, Ventricular</condition>
  <arm_group>
    <arm_group_label>SERF Catheter Ablation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Saline-Enhanced Radiofrequency Catheter and Ablation System</intervention_name>
    <description>Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter</description>
    <arm_group_label>SERF Catheter Ablation</arm_group_label>
    <other_name>SERF Ablation System and Durablate™ Ablation Catheter</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Patient has recurrent, symptomatic, monomorphic VT&#xD;
&#xD;
          2. Patient has drug refractory or drug intolerant VT following use of at least one Class&#xD;
             III antiarrhythmic as demonstrated by a recurrent arrhythmia and is not a suitable&#xD;
             candidate per the investigator's expert opinion for ongoing or alternative drug&#xD;
             therapy&#xD;
&#xD;
          3. A prior failed ablation as evidenced by ICD device therapy within the prior 6 months.&#xD;
&#xD;
          4. Patient has minimum 3 month ICD interrogation history available for evaluation&#xD;
&#xD;
          5. Patient has LVEF &gt; 20%, confirmed by echo or comparable technique during baseline&#xD;
             evaluation&#xD;
&#xD;
          6. Patient is at least 18 years old&#xD;
&#xD;
          7. Patient has signed the informed consent, and is willing and able to participate in all&#xD;
             study procedures and follow up requirements&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Patients with idiopathic VT&#xD;
&#xD;
          2. Patients with VT with ECG or MRI/CT findings suggestive of right ventricular free wall&#xD;
             origin findings.&#xD;
&#xD;
          3. Patients with VTs of septal origin may be excluded as such ablations require special&#xD;
             care to minimize the risk of heart block, particularly within 2 cm of the AV&#xD;
             node/proximal conduction system. Patients requiring ablation at such locations should&#xD;
             only be included when the arrhythmia itself is life-threatening or otherwise&#xD;
             sufficiently severe to justify the risk.&#xD;
&#xD;
          4. Patient with myocardial infarction (MI) or unstable angina within previous 60 days&#xD;
&#xD;
          5. Patient with cardiac surgery or percutaneous coronary intervention (PCI) within&#xD;
             previous 60 days&#xD;
&#xD;
          6. Patient with class IV (NYHA) heart failure&#xD;
&#xD;
          7. Patient with mechanical mitral valve, severe aortic stenosis or flail mitral leaflet&#xD;
&#xD;
          8. Patient with left ventricular assist device planned or required for the procedure&#xD;
&#xD;
          9. Patients with co-morbidities such that they have less than 1 year life expectancy&#xD;
&#xD;
         10. Patient with significant intracardiac and/or laminated thrombus evident by&#xD;
             transesophogeal echo (TEE) or transthoracic echo (TTE) (with contrast) within 2 days&#xD;
             of the ablation procedure&#xD;
&#xD;
         11. Patient with thrombocytopenia or other coagulopathy&#xD;
&#xD;
         12. Women who are or may potentially be pregnant. (must be post-menopausal or have a&#xD;
             negative pregnancy test)&#xD;
&#xD;
         13. Patient with other acute illness or active systemic infection (unrelated to VT or its&#xD;
             origin)&#xD;
&#xD;
         14. Significant congenital anomaly heart disease or anomaly&#xD;
&#xD;
         15. Allergy or contraindications to the medications/agents used during a standard&#xD;
             ablation/EP intervention.&#xD;
&#xD;
         16. Patient concurrently enrolled in any other investigational drug or device study that&#xD;
             the investigator deems would interfere with study results.&#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>Douglas L. Packer, MD</last_name>
    <role>Study Director</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Atul Verma, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Southlake Regional Health Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southlake Regional Health Centre</name>
      <address>
        <city>Newmarket</city>
        <state>Ontario</state>
        <zip>L3Y-2P6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montreal Heart Institute - Institut de Cardiologie de Montréal</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H1T 1C8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quebec Heart and Lung Institute - Institut universitaire de cardiologie et de pneumologie de Québec</name>
      <address>
        <city>Québec</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>December 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>April 27, 2022</last_update_submitted>
  <last_update_submitted_qc>April 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 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>Tachycardia</mesh_term>
    <mesh_term>Tachycardia, Ventricular</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/NCT02994446
org study id: RD-14-001P
nct id: NCT02994446
lead sponsor: 
has dmc: Yes
The purpose of this study is to demonstrate the technical feasibility of the SERF Catheter
      and SERF Cardiac Ablation System to eliminate or control ventricular tachycardia (VT)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Serious Adverse Events that are potentially device-related
time frame: Within 30 days of ablation
measure: Major Adverse Cardiac Events
time frame: Within 2 days after ablation procedure
description: MACE will be accessed from time of ablation to time of discharge from hospital following the ablation (generally within 2 days of ablation procedure).
measure: Non-inducibility of clinical ventricular tachycardia (VT) and/or elimination of clinically relevant scar or channels
time frame: At completion of ablation procedure
measure: Intraprocedural non-inducibility and/or scar homogenization of target VT
time frame: At completion of ablation procedure
measure: Elimination of the target VT and/or reduction in number of VT episodes
time frame: Within first 6 months of ablation procedure
arm group label: SERF Catheter Ablation
arm group type: Experimental
description: Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter
intervention type: Device
intervention name: Saline-Enhanced Radiofrequency Catheter and Ablation System
description: Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter
arm group label: SERF Catheter Ablation
other name: SERF Ablation System and Durablate™ Ablation Catheter
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Douglas L. Packer, MD
role: Study Director
affiliation: Mayo Clinic
last name: Atul Verma, MD
role: Principal Investigator
affiliation: Southlake Regional Health Centre
facility: 
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Tachycardia
mesh term: Tachycardia, Ventricular
sharing ipd: Undecided