<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20190608043836N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-22</date_registration>
      <primary_sponsor>Sairan medical company</primary_sponsor>
      <public_title>Inferiority of ZOLL and SAIRAN Electroshocks</public_title>
      <acronym></acronym>
      <scientific_title>Comparing Effectiveness and Safety of Synchronized Electrical Cardioversion by ZOLL and SAIRAN Electroshocks in Patients with Atrial Fibrillation: A Non-Inferiority Double Blinded Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>670</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40051</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization (block size=4) is used for random allocation of patients. Using RANDBETWEEN command in excell program, we determined sequence of blocks. With a sample and block size 670 and 4, respectively, RANDBETWEEN will be run for 168 times. After determining sequence of all blocks, a patient-specific 5-digits code will be written on a paper. Then paper is folded and put in a  dark and thick sealed envelop. Envelops will be numbered from 1 to 670 according to blocks sequences. The meaning of 5-digits code will not be clear for patients so we will have concealment. only assessors (physician) who open envelop will be informed that how they distinguish the brand of device (SaIran or Zoll). A trained and blind nurse will preserve sealed envelops securely and deliver them to assessor (physician) one at the time according to numbering on it. For example, when first patient enters to study, the first envelope, numbered 1 on it, is delivered by the responsible nurse to the physician. Physician will open it and select type of electroshok device for patient based on 5-digits code. This work will be repeated until last patient, Blinding description: There is no possibility for blinding of assessors (physicians) due to the fact that the Zoll is known to all. However, patients will be blinded via masking device brand. In addition, we will blind data analyser. So this will be a double blinded study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Atrial Fibrillation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group treated by Electroshock of Sa-Iran. Before the shock, the first part of the questionnaire, which includes demographic data and risk factors, is completed by the patient's nurse. Then patient is allocated to Sa-Iran or Zoll group. After randomizations, the patient is prepared for the shock. The patient's nurse completes the second part of the questionnaire, which includes shock data (number of shocks performed to achieve success, number of used paddles, etc.) under supervision of physician. Patients is followed up at least for 24 hours after procedure in hospital. Patient's nurse completes the third part of the questionnaire, which includes complications data (thrombotic events, Burn wound status, etc.) in 12 and 24 hours after performing shock. Intervention 2: Control group: group treated by Electroshock of Zoll. Before the shock, the first part of the questionnaire, which includes demographic data and risk factors, is completed by the patient's nurse. Then patient is allocated to Sa-Iran or Zoll group. After randomizations, the patient is prepared for the shock. The patient's nurse completes the second part of the questionnaire, which includes shock data (number of shocks performed to achieve success, number of used paddles, etc.) under supervision of physician. Patients is followed up at least for 24 hours after procedure in hospital. Patient's nurse completes the third part of the questionnaire, which includes complications data (thromboembolic events, Burn wound status, etc.) in 12 and 24 hours after performing shock.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is not more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Asieh Mansouri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan Cardiovascular Research Institute,  Shahid Rahmani Alley, Moshtagh Sevom St., Isfahan, Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8158388994</zip>
        <telephone>+98 31 3611 5215</telephone>
        <email>mansouri_a@alumnus.tums.ac.ir</email>
        <affiliation>Interventional Cardiology Research Center, Cardiovascular Research institute, Isfahan University of</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Alireza Khosravi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Interventional cardiology Research Center, Cardiovascular Research Institute,  Shahid Rahmani Alley, Moshtagh Sevom St., Isfahan, Iran.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8158388994</zip>
        <telephone>+98 31 3611 5215</telephone>
        <email>mansouri_a@alumnus.tums.ac.ir</email>
        <affiliation>Interventional Cardiology Research Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Atrial fibrillation
Definite candidate for Synchronized Electrical Cardioversion to convert cardiac rhythm from atrial fibrillation to sinus rhythm
Satisfaction</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>complicated disorders (advanced cancers, severe kidney problems (Glomerular filtration rate &lt;30), liver problems, etc)
Lack of necessary conditions for Synchronized Electrical Cardioversion</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I48</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atrial fibrillation and flutter</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group treated by Electroshock of Sa-Iran. Before the shock, the first part of the questionnaire, which includes demographic data and risk factors, is completed by the patient's nurse. Then patient is allocated to Sa-Iran or Zoll group. After randomizations, the patient is prepared for the shock. The patient's nurse completes the second part of the questionnaire, which includes shock data (number of shocks performed to achieve success, number of used paddles, etc.) under supervision of physician. Patients is followed up at least for 24 hours after procedure in hospital. Patient's nurse completes the third part of the questionnaire, which includes complications data (thrombotic events, Burn wound status, etc.) in 12 and 24 hours after performing shock.</i_keyword>
      <i_keyword>Control group: group treated by Electroshock of Zoll. Before the shock, the first part of the questionnaire, which includes demographic data and risk factors, is completed by the patient's nurse. Then patient is allocated to Sa-Iran or Zoll group. After randomizations, the patient is prepared for the shock. The patient's nurse completes the second part of the questionnaire, which includes shock data (number of shocks performed to achieve success, number of used paddles, etc.) under supervision of physician. Patients is followed up at least for 24 hours after procedure in hospital. Patient's nurse completes the third part of the questionnaire, which includes complications data (thromboembolic events, Burn wound status, etc.) in 12 and 24 hours after performing shock.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cardiac rhythm status after electroshock. Timepoint: As soon as it occurs after starting the intervention. Method of measurement: Monitoring of cardiac rhythm.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The number of shocks performed to achieve success (sinus cardiac rhythm). Timepoint: After starting intervention. Method of measurement: counting and recording in questionnaire.</sec_outcome>
      <sec_outcome>Energy consumed to achieve success. Timepoint: After starting intervention. Method of measurement: observing device monitor and recording in questionnaire.</sec_outcome>
      <sec_outcome>Needing to use a temporary pacemaker to adjust the heart rate after performing a shock. Timepoint: After starting intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Heart pulses marked correctly. Timepoint: After starting intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Skin burning at electrodes spots. Timepoint: in 12th and 24th hour after intervention. Method of measurement: observing and recording in questionnaire.</sec_outcome>
      <sec_outcome>Severity of skin burning  at electrodes spots. Timepoint: in 12th and 24th hour after intervention. Method of measurement: observing and recording in questionnaire.</sec_outcome>
      <sec_outcome>Burn wound area. Timepoint: in 12th and 24th hour after intervention. Method of measurement: observing and recording in questionnaire.</sec_outcome>
      <sec_outcome>Thromboembolic events after Electroshock. Timepoint: in 12th and 24th hour after intervention. Method of measurement: observing and writing in questionnaire.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Sairan medical company</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-28</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Floor 2, Bleeding No.4, Isfahan University of M Hezarjerib Street Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
