<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/NCT02209064</url>
  </required_header>
  <id_info>
    <org_study_id>DR-002 (rev C)</org_study_id>
    <nct_id>NCT02209064</nct_id>
  </id_info>
  <brief_title>&quot;EASE&quot; Epicardial Access With the EpiAccess System</brief_title>
  <acronym>EASE2</acronym>
  <official_title>EASe 2- an Epicardial Access Study With the EpiAccess System- A Post-market Follow up Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>EpiEP, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>EpiEP, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective non-randomized, single arm trial to further evaluate the safety and performance&#xD;
      of EpiAccess, the study device, for gaining access to the normal, non-distended pericardial&#xD;
      space during epicardial diagnostic or therapeutic (ablation) procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prior to enrolment, patients will be evaluated on the basis of the latest available data to&#xD;
      establish eligibility. Eligible patients will be enrolled in the study by the local principal&#xD;
      investigator after informed consent is obtained.&#xD;
&#xD;
      As EpiAccess is only used for the access portion of electrophysiology procedures, the safety,&#xD;
      performance and effectiveness endpoints are acute from the time of needle insertion to&#xD;
      pericardial space access (guidewire insertion into the pericardial sac). Patients will be&#xD;
      followed until hospital discharge. Follow-up clinical examinations will be performed in&#xD;
      accordance with institutions' standard of care. No special tests are required for this&#xD;
      device. Patients' completion of study will occur at the time of their hospital discharge, or&#xD;
      earlier if patient did not complete the study.&#xD;
&#xD;
      The stop criterion for this study is: greater than 25% Serious Adverse Device Effect, as&#xD;
      defined in this protocol, after enrolment of 10 or more patients, compared to existing data&#xD;
      from the literature presenting epicardial access procedure results during sub-xyphoid&#xD;
      (minimally invasive) surgical procedures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2013</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants in Whom Pericardial Access Was Achieved With the EpiAccess System</measure>
    <time_frame>Through discharge / approx 4 days</time_frame>
    <description>EpiAccess device shall be used to access the pericardial space with measurements tracked noting if access was achieved. The percentage of patients in whom pericardial access was successful will be reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants in Whom Equivalent or Better Access Was Achieved With EpiAccess System</measure>
    <time_frame>access through procedure completion</time_frame>
    <description>EpiAccess will provide equivalent or better access (defined as guidewire entry into the pericardial space) as compared to access with standard of care minimally invasive, subxiphoid access techniques.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a Pericardial Effusion of &gt;80ml</measure>
    <time_frame>Access through discharge/approximately 4 days</time_frame>
    <description>Secondary endpoint will measure whether or not there was a pericardial effusion greater than 80ml.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Patients in Whom Pericardial Access Was Achieved With the EpiAccess System</measure>
    <time_frame>Access through end of procedure</time_frame>
    <description>Number of patients in whom the EpiAccess system was equivalently able to access the pericardial space, compared with standard of care minimally invasive access techniques,documented by using intra procedure or post procedure clinician survey</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Arrhythmias, Cardiac</condition>
  <arm_group>
    <arm_group_label>EpiAccess</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>EpiAccess will be used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pericardial access</intervention_name>
    <description>Access to the pericardium to enable further treatments.</description>
    <arm_group_label>EpiAccess</arm_group_label>
    <other_name>EpiAccess</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient is 18 years of age or older&#xD;
&#xD;
          2. Pericardial access is clinically indicated&#xD;
&#xD;
          3. Patient is willing and able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient with history of cardiac or pericardial surgery in the past 6 months&#xD;
&#xD;
          2. Patient with history of chronic pericarditis&#xD;
&#xD;
          3. Myocardial infarction within 4 weeks prior to procedure&#xD;
&#xD;
          4. Class IV NYHA (New York Heart Association) heart failure symptoms&#xD;
&#xD;
          5. Cerebrovascular accident within previous 6 months&#xD;
&#xD;
          6. Known carotid artery stenosis greater than 80%&#xD;
&#xD;
          7. Presence of thrombus in the left atrium&#xD;
&#xD;
          8. Coagulopathy&#xD;
&#xD;
          9. Severe Hepatic Dysfunction or Enlargement&#xD;
&#xD;
         10. Life expectancy less than 6 months&#xD;
&#xD;
         11. BMI &gt; 40&#xD;
&#xD;
         12. Patient is enrolled in another clinical trial&#xD;
&#xD;
         13. Patient is pregnant&#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>Andrea Natale, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Debrecen, Cardiology/Electrophysiology Department; Debrecen, Hungary</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nemocnice Na Homolka</name>
      <address>
        <city>Prague</city>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czech Republic</country>
  </location_countries>
  <reference>
    <citation>Tedrow U, Stevenson WG. Strategies for epicardial mapping and ablation of ventricular tachycardia. J Cardiovasc Electrophysiol. 2009 Jun;20(6):710-3. doi: 10.1111/j.1540-8167.2008.01427.x. Epub 2009 Feb 2.</citation>
    <PMID>19207780</PMID>
  </reference>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <results_first_submitted>November 16, 2015</results_first_submitted>
  <results_first_submitted_qc>February 8, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 7, 2016</results_first_posted>
  <last_update_submitted>February 8, 2016</last_update_submitted>
  <last_update_submitted_qc>February 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Subxiphoid</keyword>
  <keyword>Access</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>25 Patients were enrolled at five sites in Europe between February 7th 2014 and March 16, 2015</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>EpiAccess</title>
          <description>EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.&#xD;
Pericardial access: Access to the pericardium to enable further treatments.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>EpiAccess</title>
          <description>EpiAccess will be used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.&#xD;
Pericardial access: Access to the pericardium to enable further treatments.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.9" lower_limit="28.4" upper_limit="84.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Czech Republic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants in Whom Pericardial Access Was Achieved With the EpiAccess System</title>
        <description>EpiAccess device shall be used to access the pericardial space with measurements tracked noting if access was achieved. The percentage of patients in whom pericardial access was successful will be reported.</description>
        <time_frame>Through discharge / approx 4 days</time_frame>
        <population>Percentage of patients in whom epicardial access was successful using the EpiAccess system. Successful access is defined as the ability to introduce a guide wire into the epicardial space.</population>
        <group_list>
          <group group_id="O1">
            <title>EpiAccess</title>
            <description>EpiAccess will be used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.&#xD;
Pericardial access: Access to the pericardium to enable further treatments.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants in Whom Pericardial Access Was Achieved With the EpiAccess System</title>
          <description>EpiAccess device shall be used to access the pericardial space with measurements tracked noting if access was achieved. The percentage of patients in whom pericardial access was successful will be reported.</description>
          <population>Percentage of patients in whom epicardial access was successful using the EpiAccess system. Successful access is defined as the ability to introduce a guide wire into the epicardial space.</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants in Whom Equivalent or Better Access Was Achieved With EpiAccess System</title>
        <description>EpiAccess will provide equivalent or better access (defined as guidewire entry into the pericardial space) as compared to access with standard of care minimally invasive, subxiphoid access techniques.</description>
        <time_frame>access through procedure completion</time_frame>
        <group_list>
          <group group_id="O1">
            <title>EpiAccess</title>
            <description>EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.&#xD;
Pericardial access: Access to the pericardium to enable further treatments.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants in Whom Equivalent or Better Access Was Achieved With EpiAccess System</title>
          <description>EpiAccess will provide equivalent or better access (defined as guidewire entry into the pericardial space) as compared to access with standard of care minimally invasive, subxiphoid access techniques.</description>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a Pericardial Effusion of &gt;80ml</title>
        <description>Secondary endpoint will measure whether or not there was a pericardial effusion greater than 80ml.</description>
        <time_frame>Access through discharge/approximately 4 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>EpiAccess</title>
            <description>EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.&#xD;
Pericardial access: Access to the pericardium to enable further treatments.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Pericardial Effusion of &gt;80ml</title>
          <description>Secondary endpoint will measure whether or not there was a pericardial effusion greater than 80ml.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Patients in Whom Pericardial Access Was Achieved With the EpiAccess System</title>
        <description>Number of patients in whom the EpiAccess system was equivalently able to access the pericardial space, compared with standard of care minimally invasive access techniques,documented by using intra procedure or post procedure clinician survey</description>
        <time_frame>Access through end of procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>EpiAccess</title>
            <description>EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.&#xD;
Pericardial access: Access to the pericardium to enable further treatments.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients in Whom Pericardial Access Was Achieved With the EpiAccess System</title>
          <description>Number of patients in whom the EpiAccess system was equivalently able to access the pericardial space, compared with standard of care minimally invasive access techniques,documented by using intra procedure or post procedure clinician survey</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>EpiAccess</title>
          <description>EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.&#xD;
Pericardial access: Access to the pericardium to enable further treatments.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>4</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Unintended right ventricular puncture</sub_title>
                <description>Right ventricular puncture without pericardial effusion due to patient anatomy and not related to use of the EpiAccess System</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pericardial Effusion</sub_title>
                <description>Pericardial effusion requiring treatment not associated with use of the EpiAccess System</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Acute ischemia of left superficial femoral artery</sub_title>
                <description>Not device or access related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pam Bunes CEO &amp; Founder</name_or_title>
      <organization>EpiEP</organization>
      <phone>+1 864 423 2526</phone>
      <email>pbunes@epiep.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02209064
org study id: DR-002 (rev C)
nct id: NCT02209064
lead sponsor: 
has dmc: Yes
Prospective non-randomized, single arm trial to further evaluate the safety and performance
      of EpiAccess, the study device, for gaining access to the normal, non-distended pericardial
      space during epicardial diagnostic or therapeutic (ablation) procedures.
Prior to enrolment, patients will be evaluated on the basis of the latest available data to
      establish eligibility. Eligible patients will be enrolled in the study by the local principal
      investigator after informed consent is obtained.

      As EpiAccess is only used for the access portion of electrophysiology procedures, the safety,
      performance and effectiveness endpoints are acute from the time of needle insertion to
      pericardial space access (guidewire insertion into the pericardial sac). Patients will be
      followed until hospital discharge. Follow-up clinical examinations will be performed in
      accordance with institutions' standard of care. No special tests are required for this
      device. Patients' completion of study will occur at the time of their hospital discharge, or
      earlier if patient did not complete the study.

      The stop criterion for this study is: greater than 25% Serious Adverse Device Effect, as
      defined in this protocol, after enrolment of 10 or more patients, compared to existing data
      from the literature presenting epicardial access procedure results during sub-xyphoid
      (minimally invasive) surgical procedures.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Percentage of Participants in Whom Pericardial Access Was Achieved With the EpiAccess System
time frame: Through discharge / approx 4 days
description: EpiAccess device shall be used to access the pericardial space with measurements tracked noting if access was achieved. The percentage of patients in whom pericardial access was successful will be reported.
measure: Percentage of Participants in Whom Equivalent or Better Access Was Achieved With EpiAccess System
time frame: access through procedure completion
description: EpiAccess will provide equivalent or better access (defined as guidewire entry into the pericardial space) as compared to access with standard of care minimally invasive, subxiphoid access techniques.
measure: Percentage of Participants With a Pericardial Effusion of >80ml
time frame: Access through discharge/approximately 4 days
description: Secondary endpoint will measure whether or not there was a pericardial effusion greater than 80ml.
measure: Number of Patients in Whom Pericardial Access Was Achieved With the EpiAccess System
time frame: Access through end of procedure
description: Number of patients in whom the EpiAccess system was equivalently able to access the pericardial space, compared with standard of care minimally invasive access techniques,documented by using intra procedure or post procedure clinician survey
arm group label: EpiAccess
arm group type: Other
description: EpiAccess will be used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.
intervention type: Device
intervention name: Pericardial access
description: Access to the pericardium to enable further treatments.
arm group label: EpiAccess
other name: EpiAccess
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrea Natale, MD
role: Principal Investigator
affiliation: University of Debrecen, Cardiology/Electrophysiology Department; Debrecen, Hungary
facility: 
country: Czech Republic
citation: Tedrow U, Stevenson WG. Strategies for epicardial mapping and ablation of ventricular tachycardia. J Cardiovasc Electrophysiol. 2009 Jun;20(6):710-3. doi: 10.1111/j.1540-8167.2008.01427.x. Epub 2009 Feb 2.
PMID: 19207780
responsible party type: Sponsor
mesh term: Arrhythmias, Cardiac
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 