<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/NCT04404257</url>
  </required_header>
  <id_info>
    <org_study_id>2019-174</org_study_id>
    <nct_id>NCT04404257</nct_id>
  </id_info>
  <brief_title>Reduce Radiation Exposure in Fluoroscopic Interventions Evaluation</brief_title>
  <acronym>REDEFINE</acronym>
  <official_title>Reduce Radiation Exposure in Fluoroscopic Interventions Evaluation (REDEFINE): A Prospective, Randomized Evaluation of the ControlRad System to Reduce Radiation Exposure During Cardiac Catheterization and Electrophysiology (EP) Procedures.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>William Beaumont Hospitals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>William Beaumont Hospitals</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>
      The purpose of this study is to determine whether the ControlRad system device when installed&#xD;
      in Fluoroscopic (x-ray) machine reduces radiation dose to operators (Doctors and nurses) and&#xD;
      to the patient who is undergoing cardiac Catheterization and electrophysiology (EP) implant&#xD;
      procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Prospective, randomized (like a &quot;flip of a coin&quot;) single center study evaluating&#xD;
      the ControlRad system device when installed - retrofitted on existing C-arms for fluoroscopy&#xD;
      (x-ray) will reduce radiation exposure without compromising image quality in the region of&#xD;
      interest and overall workflow during cardiac catheterization and electrophysiology (EP)&#xD;
      implant procedures. Enrollment will be limited to 40 cardiac catheterization, and 30&#xD;
      pacemaker and/or ICD procedures. All patients presenting to Beaumont Hospital Royal Oak who&#xD;
      are scheduled for cardiac catheterization with coronary angiography and electrophysiology&#xD;
      implant in Cath Lab 5 where device is installed will be considered for inclusion in the&#xD;
      study. Physicians and staff (20 fellows; 35 attending physicians; and 56 Cath-lab&#xD;
      staff,including Nurse/Anesthesia team) will be invited to participate in the study. For each&#xD;
      procedure, 3 staff members will be study subjects: a) the primary operator, b) the secondary&#xD;
      operator, c) the nurse/tech and or Anesthetist who circulates in the room. Different&#xD;
      operators and staff may participate in each case depending on cath-lab scheduling. The&#xD;
      Primary operator is the physician who usually stands nearest to the C-arm. In most cases in&#xD;
      Beaumont this is a Cardiology Fellow in cardiac catheterization cases and Attending Physician&#xD;
      for the EP cases. The Secondary operator is the physician who typically stands to the right&#xD;
      of the primary operator and in most cases is the attending cardiologist or scrub assistant&#xD;
      (nurse/technician). The Nurse or Anesthesia team typically circulates in the room and is&#xD;
      responsible for monitoring the patient, administering medications and obtaining equipment for&#xD;
      the procedure.&#xD;
&#xD;
      Two methods will be used to measure radiation dose during the catheterization procedure. The&#xD;
      Real-time Dosimeter Badge (RaySafe) and the Landauer Luxel Aluminium Oxide Dosimeter Badges.&#xD;
      Cardiac Catheterization and electrophysiology implant procedures will be performed according&#xD;
      to standard guidelines.&#xD;
&#xD;
      Participants will be randomized 1:1 to either cardiac catheterization without ControlRad or&#xD;
      cardiac catheterization with the ControlRad system. The same 1:1 randomization process will&#xD;
      be applied to the EP patient population. Participants will be blinded to the randomization.&#xD;
&#xD;
      Once procedure is done,participation also ended and the badges will be removed by the&#xD;
      Radiation Safety Officer or research coordinator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 5, 2020</start_date>
  <completion_date type="Actual">December 3, 2021</completion_date>
  <primary_completion_date type="Actual">December 3, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized 1:1 like a flip of a coin, to receive either cardiac catheterization and or electrophysiology implant procedures without ControlRad system or cardiac catheterization and or electrophysiology (EP) implant procedures with the ControlRad system.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participant will be blinded to the arm assigned to; but the investigators, cath lab operators and staff will be informed of the randomized assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Radiation Dose to Primary Operator (RaySafe), Cardiac Catheterization</measure>
    <time_frame>During each cardiac catheterization, an average of 90 minutes</time_frame>
    <description>Median effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiation Dose to Primary Operator (Luxel Dosimeter), Cardiac Catheterization</measure>
    <time_frame>During each cardiac catheterization, an average of 90 minutes</time_frame>
    <description>Mean effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiation Dose to Primary Operator, EP Procedure (Luxel)</measure>
    <time_frame>During each EP implant procedure, an average of 90 minutes</time_frame>
    <description>Mean effective radiation dose in microsievert (μSv) to the primary operator at the end of each EP implant procedure. A single Luxel dosimeter was and a cumulative dose was recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiation Dose to Primary Operator, EP Procedure (RaySafe)</measure>
    <time_frame>During each EP implant procedure, an average of 90 minutes duration</time_frame>
    <description>Median effective radiation dose in microsievert (μSv) to the primary operator at the end of each EP implant procedure using a RaySafe dosimeter. This is measured after each case.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiation Dose to Secondary Operator, Cardiac Catheterization (RaySafe)</measure>
    <time_frame>During each cardiac catheterization, an average of 90 minutes</time_frame>
    <description>Median effective radiation dose (μSv) to the secondary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiation Dose to Secondary Operator (Luxel Dosimeter), Cardiac Catheterization</measure>
    <time_frame>During each cardiac catheterization, an average of 90 minutes</time_frame>
    <description>Mean effective radiation dose in microsievert (μSv) to the secondary operator at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (RaySafe)</measure>
    <time_frame>During each cardiac catheterization, an average of 90 minutes</time_frame>
    <description>Median effective radiation dose in microsievert (μSv) to the Nurse 0r Anesthetist at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (Luxel)</measure>
    <time_frame>During each cardiac catheterization, an average of 90 minutes</time_frame>
    <description>Mean effective radiation dose in microsievert (μSv) to the Nurse or Anesthetist at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiation Dose to Patient, Cardiac Catheterization</measure>
    <time_frame>During each cardiac catheterization, an average of 90 minutes</time_frame>
    <description>Median radiation dose-area product (DAP) to the patient at the end of each cardiac catheterization case using data from a fluoroscopy machine. DAP is defined as the absorbed dose multiplied by the area irradiated micro-gray μGy*m^2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiation Dose in Cath Lab Room #5, Cardiac Catheterization</measure>
    <time_frame>During each cardiac catheterization, an average of 90 minutes</time_frame>
    <description>Mean radiation dose microsieverts (μSv) at the end of each cardiac catheterization case at a standard location on the wall of the catheterization laboratory. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiation Dose to Secondary Operator, EP Procedure (RaySafe)</measure>
    <time_frame>During each EP implant procedure, an average of 90 minutes</time_frame>
    <description>Mean effective radiation dose (μSv) to the secondary operator at the at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiation Dose to Secondary Operator, EP Procedure (Luxel)</measure>
    <time_frame>During each EP implant procedure, an average of 90 minutes</time_frame>
    <description>Mean effective radiation dose (μSv) to the secondary operator at the at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiation Dose to Nurse or Anesthetist, EP Procedure (RaySafe)</measure>
    <time_frame>During each EP implant procedure, an average of 90 minutes</time_frame>
    <description>Median effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiation Dose to Nurse or Anesthetist, EP Procedure (Luxel)</measure>
    <time_frame>During each EP implant procedure, an average of 90 minutes</time_frame>
    <description>Mean effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiation Dose to Patient, EP Procedure</measure>
    <time_frame>During each EP implant procedure, an average of 30-45 minutes of active radiation</time_frame>
    <description>Mean radiation dose-area product (DAP) to the patient at the end of each EP implant procedure using data from a fluoroscopy machine. DAP is defined as the absorbed dose multiplied by the area irradiated (μGy*m^2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiation Dose in Cath Lab Room #5, EP Procedure</measure>
    <time_frame>During each EP implant procedure, an average of 90 minutes</time_frame>
    <description>Mean radiation dose (μSv) at the end of each EP implant procedure at a standard location on the wall of the catheterization laboratory. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">170</enrollment>
  <condition>Cardiac Catheterization</condition>
  <condition>Radiation Exposure</condition>
  <arm_group>
    <arm_group_label>ControlRad System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Without ControlRad System</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>ControlRad System</intervention_name>
    <description>Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.</description>
    <arm_group_label>ControlRad System</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Without ControlRad System</intervention_name>
    <description>Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.</description>
    <arm_group_label>Without ControlRad System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  - Patient&#xD;
&#xD;
               -  Scheduled to undergo left heart catheterization with angiography, and/or&#xD;
                  percutaneous coronary intervention&#xD;
&#xD;
               -  Scheduled to undergo pacemaker or ICD implant&#xD;
&#xD;
               -  EP device upgrade&#xD;
&#xD;
               -  Able to provide written informed consent prior to the procedure&#xD;
&#xD;
               -  Age ≥18 years&#xD;
&#xD;
          -  Physicians and Staff o Able to provide consent for the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Patient&#xD;
&#xD;
               -  Cardiogenic shock&#xD;
&#xD;
               -  Reason for cath procedure is pericardiocentesis&#xD;
&#xD;
               -  Subcutaneous ICDs&#xD;
&#xD;
               -  Lead revisions&#xD;
&#xD;
               -  Inability to provide informed consent&#xD;
&#xD;
               -  Pregnant&#xD;
&#xD;
          -  Physicians and Staff&#xD;
&#xD;
               -  Those who are not willing to participate in the study&#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>Simon Dixon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>William Beaumont Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beaumont Hospital - Royal Oak</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>April 8, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <results_first_submitted>November 9, 2022</results_first_submitted>
  <results_first_submitted_qc>December 20, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 11, 2023</results_first_posted>
  <last_update_submitted>December 20, 2022</last_update_submitted>
  <last_update_submitted_qc>December 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>William Beaumont Hospitals</investigator_affiliation>
    <investigator_full_name>Simon Dixon, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>ControlRad System</keyword>
  <keyword>Cardiac Catheterization</keyword>
  <keyword>Radiation Exposure</keyword>
  <keyword>Fluoroscopic x-ray</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 14, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/57/NCT04404257/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>ControlRad System</title>
          <description>Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5&#xD;
ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.</description>
        </group>
        <group group_id="P2">
          <title>Without ControlRad System</title>
          <description>Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5.&#xD;
Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="85"/>
                <participants group_id="P2" count="85"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="85"/>
                <participants group_id="P2" count="85"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ControlRad System</title>
          <description>Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5&#xD;
ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.</description>
        </group>
        <group group_id="B2">
          <title>Without ControlRad System</title>
          <description>Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5.&#xD;
Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="85"/>
            <count group_id="B2" value="85"/>
            <count group_id="B3" value="170"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="85"/>
                    <count group_id="B2" value="85"/>
                    <count group_id="B3" value="170"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70.3" spread="4.6"/>
                    <measurement group_id="B2" value="57.1" spread="9.9"/>
                    <measurement group_id="B3" value="63.7" spread="1.2"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="85"/>
                    <count group_id="B2" value="85"/>
                    <count group_id="B3" value="170"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </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>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="85"/>
                    <count group_id="B2" value="85"/>
                    <count group_id="B3" value="170"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="85"/>
                    <measurement group_id="B3" value="170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Radiation Dose to Primary Operator (RaySafe), Cardiac Catheterization</title>
        <description>Median effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.</description>
        <time_frame>During each cardiac catheterization, an average of 90 minutes</time_frame>
        <population>This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad</population>
        <group_list>
          <group group_id="O1">
            <title>ControlRad System</title>
            <description>Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5&#xD;
ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.</description>
          </group>
          <group group_id="O2">
            <title>Without ControlRad System</title>
            <description>Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5.&#xD;
Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.</description>
          </group>
        </group_list>
        <measure>
          <title>Radiation Dose to Primary Operator (RaySafe), Cardiac Catheterization</title>
          <description>Median effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.</description>
          <population>This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad</population>
          <units>microsievert</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18" lower_limit="7" upper_limit="35"/>
                    <measurement group_id="O2" value="39" lower_limit="19" upper_limit="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Radiation Dose to Primary Operator (Luxel Dosimeter), Cardiac Catheterization</title>
        <description>Mean effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.</description>
        <time_frame>During each cardiac catheterization, an average of 90 minutes</time_frame>
        <population>This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.</population>
        <group_list>
          <group group_id="O1">
            <title>ControlRad System</title>
            <description>Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5&#xD;
ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.</description>
          </group>
          <group group_id="O2">
            <title>Without ControlRad System</title>
            <description>Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5.&#xD;
Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.</description>
          </group>
        </group_list>
        <measure>
          <title>Radiation Dose to Primary Operator (Luxel Dosimeter), Cardiac Catheterization</title>
          <description>Mean effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.</description>
          <population>This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.</population>
          <units>microsievert</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Radiation Dose to Primary Operator, EP Procedure (Luxel)</title>
        <description>Mean effective radiation dose in microsievert (μSv) to the primary operator at the end of each EP implant procedure. A single Luxel dosimeter was and a cumulative dose was recorded.</description>
        <time_frame>During each EP implant procedure, an average of 90 minutes</time_frame>
        <population>This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.</population>
        <group_list>
          <group group_id="O1">
            <title>ControlRad System</title>
            <description>Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5&#xD;
ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.</description>
          </group>
          <group group_id="O2">
            <title>Without ControlRad System</title>
            <description>Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5.&#xD;
Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.</description>
          </group>
        </group_list>
        <measure>
          <title>Radiation Dose to Primary Operator, EP Procedure (Luxel)</title>
          <description>Mean effective radiation dose in microsievert (μSv) to the primary operator at the end of each EP implant procedure. A single Luxel dosimeter was and a cumulative dose was recorded.</description>
          <population>This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.</population>
          <units>microsieverts</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.7"/>
                    <measurement group_id="O2" value="58.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Radiation Dose to Primary Operator, EP Procedure (RaySafe)</title>
        <description>Median effective radiation dose in microsievert (μSv) to the primary operator at the end of each EP implant procedure using a RaySafe dosimeter. This is measured after each case.</description>
        <time_frame>During each EP implant procedure, an average of 90 minutes duration</time_frame>
        <population>This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group.</population>
        <group_list>
          <group group_id="O1">
            <title>ControlRad System</title>
            <description>Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5&#xD;
ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.</description>
          </group>
          <group group_id="O2">
            <title>Without ControlRad System</title>
            <description>Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5.&#xD;
Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.</description>
          </group>
        </group_list>
        <measure>
          <title>Radiation Dose to Primary Operator, EP Procedure (RaySafe)</title>
          <description>Median effective radiation dose in microsievert (μSv) to the primary operator at the end of each EP implant procedure using a RaySafe dosimeter. This is measured after each case.</description>
          <population>This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group.</population>
          <units>microsieverts</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25" lower_limit="15" upper_limit="69.5"/>
                    <measurement group_id="O2" value="61" lower_limit="25.5" upper_limit="149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Radiation Dose to Secondary Operator, Cardiac Catheterization (RaySafe)</title>
        <description>Median effective radiation dose (μSv) to the secondary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.</description>
        <time_frame>During each cardiac catheterization, an average of 90 minutes</time_frame>
        <population>This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad</population>
        <group_list>
          <group group_id="O1">
            <title>ControlRad System</title>
            <description>Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5&#xD;
ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.</description>
          </group>
          <group group_id="O2">
            <title>Without ControlRad System</title>
            <description>Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5.&#xD;
Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.</description>
          </group>
        </group_list>
        <measure>
          <title>Radiation Dose to Secondary Operator, Cardiac Catheterization (RaySafe)</title>
          <description>Median effective radiation dose (μSv) to the secondary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.</description>
          <population>This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad</population>
          <units>microsievert</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12" lower_limit="6" upper_limit="22"/>
                    <measurement group_id="O2" value="21" lower_limit="13" upper_limit="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Radiation Dose to Secondary Operator (Luxel Dosimeter), Cardiac Catheterization</title>
        <description>Mean effective radiation dose in microsievert (μSv) to the secondary operator at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.</description>
        <time_frame>During each cardiac catheterization, an average of 90 minutes</time_frame>
        <population>This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.</population>
        <group_list>
          <group group_id="O1">
            <title>ControlRad System</title>
            <description>Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5&#xD;
ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.</description>
          </group>
          <group group_id="O2">
            <title>Without ControlRad System</title>
            <description>Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5.&#xD;
Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.</description>
          </group>
        </group_list>
        <measure>
          <title>Radiation Dose to Secondary Operator (Luxel Dosimeter), Cardiac Catheterization</title>
          <description>Mean effective radiation dose in microsievert (μSv) to the secondary operator at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.</description>
          <population>This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.</population>
          <units>microsievert</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (RaySafe)</title>
        <description>Median effective radiation dose in microsievert (μSv) to the Nurse 0r Anesthetist at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.</description>
        <time_frame>During each cardiac catheterization, an average of 90 minutes</time_frame>
        <population>This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad</population>
        <group_list>
          <group group_id="O1">
            <title>ControlRad System</title>
            <description>Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5&#xD;
ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.</description>
          </group>
          <group group_id="O2">
            <title>Without ControlRad System</title>
            <description>Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5.&#xD;
Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.</description>
          </group>
        </group_list>
        <measure>
          <title>Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (RaySafe)</title>
          <description>Median effective radiation dose in microsievert (μSv) to the Nurse 0r Anesthetist at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.</description>
          <population>This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad</population>
          <units>microsievert</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Dosage data unreliable as it is below lower limits of detection</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Dosage data unreliable as it is below lower limits of detection</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (Luxel)</title>
        <description>Mean effective radiation dose in microsievert (μSv) to the Nurse or Anesthetist at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.</description>
        <time_frame>During each cardiac catheterization, an average of 90 minutes</time_frame>
        <population>This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad</population>
        <group_list>
          <group group_id="O1">
            <title>ControlRad System</title>
            <description>Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5&#xD;
ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.</description>
          </group>
          <group group_id="O2">
            <title>Without ControlRad System</title>
            <description>Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5.&#xD;
Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.</description>
          </group>
        </group_list>
        <measure>
          <title>Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (Luxel)</title>
          <description>Mean effective radiation dose in microsievert (μSv) to the Nurse or Anesthetist at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.</description>
          <population>This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad</population>
          <units>microsievert</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Dosage data unreliable as it is below lower limits of detection</measurement>
                    <measurement group_id="O2" value="NA">Dosage data unreliable as it is below lower limits of detection</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Radiation Dose to Patient, Cardiac Catheterization</title>
        <description>Median radiation dose-area product (DAP) to the patient at the end of each cardiac catheterization case using data from a fluoroscopy machine. DAP is defined as the absorbed dose multiplied by the area irradiated micro-gray μGy*m^2.</description>
        <time_frame>During each cardiac catheterization, an average of 90 minutes</time_frame>
        <population>This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad</population>
        <group_list>
          <group group_id="O1">
            <title>ControlRad System</title>
            <description>Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5&#xD;
ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.</description>
          </group>
          <group group_id="O2">
            <title>Without ControlRad System</title>
            <description>Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5.&#xD;
Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.</description>
          </group>
        </group_list>
        <measure>
          <title>Radiation Dose to Patient, Cardiac Catheterization</title>
          <description>Median radiation dose-area product (DAP) to the patient at the end of each cardiac catheterization case using data from a fluoroscopy machine. DAP is defined as the absorbed dose multiplied by the area irradiated micro-gray μGy*m^2.</description>
          <population>This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad</population>
          <units>μGy*m^2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2276" lower_limit="1179" upper_limit="3321"/>
                    <measurement group_id="O2" value="3487" lower_limit="2257" upper_limit="5977"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Radiation Dose in Cath Lab Room #5, Cardiac Catheterization</title>
        <description>Mean radiation dose microsieverts (μSv) at the end of each cardiac catheterization case at a standard location on the wall of the catheterization laboratory. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.</description>
        <time_frame>During each cardiac catheterization, an average of 90 minutes</time_frame>
        <population>This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.</population>
        <group_list>
          <group group_id="O1">
            <title>ControlRad System</title>
            <description>Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5&#xD;
ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.</description>
          </group>
          <group group_id="O2">
            <title>Without ControlRad System</title>
            <description>Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5.&#xD;
Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.</description>
          </group>
        </group_list>
        <measure>
          <title>Radiation Dose in Cath Lab Room #5, Cardiac Catheterization</title>
          <description>Mean radiation dose microsieverts (μSv) at the end of each cardiac catheterization case at a standard location on the wall of the catheterization laboratory. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.</description>
          <population>This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.</population>
          <units>microsieverts</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Radiation Dose to Secondary Operator, EP Procedure (RaySafe)</title>
        <description>Mean effective radiation dose (μSv) to the secondary operator at the at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.</description>
        <time_frame>During each EP implant procedure, an average of 90 minutes</time_frame>
        <population>This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group.</population>
        <group_list>
          <group group_id="O1">
            <title>ControlRad System</title>
            <description>Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5&#xD;
ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.</description>
          </group>
          <group group_id="O2">
            <title>Without ControlRad System</title>
            <description>Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5.&#xD;
Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.</description>
          </group>
        </group_list>
        <measure>
          <title>Radiation Dose to Secondary Operator, EP Procedure (RaySafe)</title>
          <description>Mean effective radiation dose (μSv) to the secondary operator at the at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.</description>
          <population>This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group.</population>
          <units>microsieverts</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="1.5" upper_limit="5"/>
                    <measurement group_id="O2" value="5" lower_limit="3" upper_limit="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Radiation Dose to Secondary Operator, EP Procedure (Luxel)</title>
        <description>Mean effective radiation dose (μSv) to the secondary operator at the at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.</description>
        <time_frame>During each EP implant procedure, an average of 90 minutes</time_frame>
        <population>This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.</population>
        <group_list>
          <group group_id="O1">
            <title>ControlRad System</title>
            <description>Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5&#xD;
ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.</description>
          </group>
          <group group_id="O2">
            <title>Without ControlRad System</title>
            <description>Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5.&#xD;
Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.</description>
          </group>
        </group_list>
        <measure>
          <title>Radiation Dose to Secondary Operator, EP Procedure (Luxel)</title>
          <description>Mean effective radiation dose (μSv) to the secondary operator at the at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.</description>
          <population>This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.</population>
          <units>microsieverts</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Radiation Dose to Nurse or Anesthetist, EP Procedure (RaySafe)</title>
        <description>Median effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.</description>
        <time_frame>During each EP implant procedure, an average of 90 minutes</time_frame>
        <population>This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group.</population>
        <group_list>
          <group group_id="O1">
            <title>ControlRad System</title>
            <description>Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5&#xD;
ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.</description>
          </group>
          <group group_id="O2">
            <title>Without ControlRad System</title>
            <description>Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5.&#xD;
Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.</description>
          </group>
        </group_list>
        <measure>
          <title>Radiation Dose to Nurse or Anesthetist, EP Procedure (RaySafe)</title>
          <description>Median effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.</description>
          <population>This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group.</population>
          <units>microsieverts</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O2" value="2" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Radiation Dose to Nurse or Anesthetist, EP Procedure (Luxel)</title>
        <description>Mean effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.</description>
        <time_frame>During each EP implant procedure, an average of 90 minutes</time_frame>
        <population>This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.</population>
        <group_list>
          <group group_id="O1">
            <title>ControlRad System</title>
            <description>Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5&#xD;
ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.</description>
          </group>
          <group group_id="O2">
            <title>Without ControlRad System</title>
            <description>Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5.&#xD;
Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.</description>
          </group>
        </group_list>
        <measure>
          <title>Radiation Dose to Nurse or Anesthetist, EP Procedure (Luxel)</title>
          <description>Mean effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.</description>
          <population>This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.</population>
          <units>microsieverts</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Radiation Dose to Patient, EP Procedure</title>
        <description>Mean radiation dose-area product (DAP) to the patient at the end of each EP implant procedure using data from a fluoroscopy machine. DAP is defined as the absorbed dose multiplied by the area irradiated (μGy*m^2)</description>
        <time_frame>During each EP implant procedure, an average of 30-45 minutes of active radiation</time_frame>
        <population>This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group.</population>
        <group_list>
          <group group_id="O1">
            <title>ControlRad System</title>
            <description>Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5&#xD;
ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.</description>
          </group>
          <group group_id="O2">
            <title>Without ControlRad System</title>
            <description>Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5.&#xD;
Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.</description>
          </group>
        </group_list>
        <measure>
          <title>Radiation Dose to Patient, EP Procedure</title>
          <description>Mean radiation dose-area product (DAP) to the patient at the end of each EP implant procedure using data from a fluoroscopy machine. DAP is defined as the absorbed dose multiplied by the area irradiated (μGy*m^2)</description>
          <population>This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group.</population>
          <units>μGy*m^2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.7" lower_limit="26" upper_limit="95.9"/>
                    <measurement group_id="O2" value="72.5" lower_limit="22.7" upper_limit="131.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Radiation Dose in Cath Lab Room #5, EP Procedure</title>
        <description>Mean radiation dose (μSv) at the end of each EP implant procedure at a standard location on the wall of the catheterization laboratory. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.</description>
        <time_frame>During each EP implant procedure, an average of 90 minutes</time_frame>
        <population>This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.</population>
        <group_list>
          <group group_id="O1">
            <title>ControlRad System</title>
            <description>Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5&#xD;
ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.</description>
          </group>
          <group group_id="O2">
            <title>Without ControlRad System</title>
            <description>Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5.&#xD;
Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.</description>
          </group>
        </group_list>
        <measure>
          <title>Radiation Dose in Cath Lab Room #5, EP Procedure</title>
          <description>Mean radiation dose (μSv) at the end of each EP implant procedure at a standard location on the wall of the catheterization laboratory. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.</description>
          <population>This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.</population>
          <units>microsieverts</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During each cardiac catheterization/EP procedure, an average of 90 minutes</time_frame>
      <group_list>
        <group group_id="E1">
          <title>ControlRad System</title>
          <description>Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5&#xD;
ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.</description>
        </group>
        <group group_id="E2">
          <title>Without ControlRad System</title>
          <description>Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5.&#xD;
Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Cardiac Perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Dr. Simon Dixon, MD</name_or_title>
      <organization>William Beaumont Hospitals</organization>
      <phone>248-898-4198</phone>
      <email>simon.dixon@beaumont.edu</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/NCT04404257
org study id: 2019-174
nct id: NCT04404257
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
The purpose of this study is to determine whether the ControlRad system device when installed
      in Fluoroscopic (x-ray) machine reduces radiation dose to operators (Doctors and nurses) and
      to the patient who is undergoing cardiac Catheterization and electrophysiology (EP) implant
      procedures.
This is a Prospective, randomized (like a "flip of a coin") single center study evaluating
      the ControlRad system device when installed - retrofitted on existing C-arms for fluoroscopy
      (x-ray) will reduce radiation exposure without compromising image quality in the region of
      interest and overall workflow during cardiac catheterization and electrophysiology (EP)
      implant procedures. Enrollment will be limited to 40 cardiac catheterization, and 30
      pacemaker and/or ICD procedures. All patients presenting to Beaumont Hospital Royal Oak who
      are scheduled for cardiac catheterization with coronary angiography and electrophysiology
      implant in Cath Lab 5 where device is installed will be considered for inclusion in the
      study. Physicians and staff (20 fellows; 35 attending physicians; and 56 Cath-lab
      staff,including Nurse/Anesthesia team) will be invited to participate in the study. For each
      procedure, 3 staff members will be study subjects: a) the primary operator, b) the secondary
      operator, c) the nurse/tech and or Anesthetist who circulates in the room. Different
      operators and staff may participate in each case depending on cath-lab scheduling. The
      Primary operator is the physician who usually stands nearest to the C-arm. In most cases in
      Beaumont this is a Cardiology Fellow in cardiac catheterization cases and Attending Physician
      for the EP cases. The Secondary operator is the physician who typically stands to the right
      of the primary operator and in most cases is the attending cardiologist or scrub assistant
      (nurse/technician). The Nurse or Anesthesia team typically circulates in the room and is
      responsible for monitoring the patient, administering medications and obtaining equipment for
      the procedure.

      Two methods will be used to measure radiation dose during the catheterization procedure. The
      Real-time Dosimeter Badge (RaySafe) and the Landauer Luxel Aluminium Oxide Dosimeter Badges.
      Cardiac Catheterization and electrophysiology implant procedures will be performed according
      to standard guidelines.

      Participants will be randomized 1:1 to either cardiac catheterization without ControlRad or
      cardiac catheterization with the ControlRad system. The same 1:1 randomization process will
      be applied to the EP patient population. Participants will be blinded to the randomization.

      Once procedure is done,participation also ended and the badges will be removed by the
      Radiation Safety Officer or research coordinator.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized 1:1 like a flip of a coin, to receive either cardiac catheterization and or electrophysiology implant procedures without ControlRad system or cardiac catheterization and or electrophysiology (EP) implant procedures with the ControlRad system.
primary purpose: Prevention
masking: Single (Participant)
masking description: Participant will be blinded to the arm assigned to; but the investigators, cath lab operators and staff will be informed of the randomized assignment.
measure: Radiation Dose to Primary Operator (RaySafe), Cardiac Catheterization
time frame: During each cardiac catheterization, an average of 90 minutes
description: Median effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.
measure: Radiation Dose to Primary Operator (Luxel Dosimeter), Cardiac Catheterization
time frame: During each cardiac catheterization, an average of 90 minutes
description: Mean effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.
measure: Radiation Dose to Primary Operator, EP Procedure (Luxel)
time frame: During each EP implant procedure, an average of 90 minutes
description: Mean effective radiation dose in microsievert (μSv) to the primary operator at the end of each EP implant procedure. A single Luxel dosimeter was and a cumulative dose was recorded.
measure: Radiation Dose to Primary Operator, EP Procedure (RaySafe)
time frame: During each EP implant procedure, an average of 90 minutes duration
description: Median effective radiation dose in microsievert (μSv) to the primary operator at the end of each EP implant procedure using a RaySafe dosimeter. This is measured after each case.
measure: Radiation Dose to Secondary Operator, Cardiac Catheterization (RaySafe)
time frame: During each cardiac catheterization, an average of 90 minutes
description: Median effective radiation dose (μSv) to the secondary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.
measure: Radiation Dose to Secondary Operator (Luxel Dosimeter), Cardiac Catheterization
time frame: During each cardiac catheterization, an average of 90 minutes
description: Mean effective radiation dose in microsievert (μSv) to the secondary operator at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.
measure: Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (RaySafe)
time frame: During each cardiac catheterization, an average of 90 minutes
description: Median effective radiation dose in microsievert (μSv) to the Nurse 0r Anesthetist at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.
measure: Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (Luxel)
time frame: During each cardiac catheterization, an average of 90 minutes
description: Mean effective radiation dose in microsievert (μSv) to the Nurse or Anesthetist at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.
measure: Radiation Dose to Patient, Cardiac Catheterization
time frame: During each cardiac catheterization, an average of 90 minutes
description: Median radiation dose-area product (DAP) to the patient at the end of each cardiac catheterization case using data from a fluoroscopy machine. DAP is defined as the absorbed dose multiplied by the area irradiated micro-gray μGy*m^2.
measure: Radiation Dose in Cath Lab Room #5, Cardiac Catheterization
time frame: During each cardiac catheterization, an average of 90 minutes
description: Mean radiation dose microsieverts (μSv) at the end of each cardiac catheterization case at a standard location on the wall of the catheterization laboratory. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.
measure: Radiation Dose to Secondary Operator, EP Procedure (RaySafe)
time frame: During each EP implant procedure, an average of 90 minutes
description: Mean effective radiation dose (μSv) to the secondary operator at the at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.
measure: Radiation Dose to Secondary Operator, EP Procedure (Luxel)
time frame: During each EP implant procedure, an average of 90 minutes
description: Mean effective radiation dose (μSv) to the secondary operator at the at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.
measure: Radiation Dose to Nurse or Anesthetist, EP Procedure (RaySafe)
time frame: During each EP implant procedure, an average of 90 minutes
description: Median effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.
measure: Radiation Dose to Nurse or Anesthetist, EP Procedure (Luxel)
time frame: During each EP implant procedure, an average of 90 minutes
description: Mean effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.
measure: Radiation Dose to Patient, EP Procedure
time frame: During each EP implant procedure, an average of 30-45 minutes of active radiation
description: Mean radiation dose-area product (DAP) to the patient at the end of each EP implant procedure using data from a fluoroscopy machine. DAP is defined as the absorbed dose multiplied by the area irradiated (μGy*m^2)
measure: Radiation Dose in Cath Lab Room #5, EP Procedure
time frame: During each EP implant procedure, an average of 90 minutes
description: Mean radiation dose (μSv) at the end of each EP implant procedure at a standard location on the wall of the catheterization laboratory. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.
arm group label: ControlRad System
arm group type: Experimental
description: Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5
arm group label: Without ControlRad System
arm group type: Active Comparator
description: Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5.
intervention type: Radiation
intervention name: ControlRad System
description: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.
arm group label: ControlRad System
intervention type: Radiation
intervention name: Without ControlRad System
description: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.
arm group label: Without ControlRad System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Simon Dixon, MD
role: Principal Investigator
affiliation: William Beaumont Hospitals
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: William Beaumont Hospitals
investigator full name: Simon Dixon, MD
investigator title: Principal Investigator
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 