<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/NCT02986282</url>
  </required_header>
  <id_info>
    <org_study_id>AFABI</org_study_id>
    <nct_id>NCT02986282</nct_id>
  </id_info>
  <brief_title>Ankle - Brachial Index Measurement in Atrial Fibrillation</brief_title>
  <acronym>AFABI</acronym>
  <official_title>Ankle - Brachial Index Measurement in Patients With Atrial Fibrillation Before and After Electrical Cardioversion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Warsaw</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Consecutive patients with atrial fibrillation will be admitted to the hospital for electrical&#xD;
      cardioversion. Ankle brachial index will be measured three times with oscillometric method&#xD;
      and three times with doppler method. Two study sessions will be performed: the first before&#xD;
      and the second after electrical cardioversion. The first session will be ended before&#xD;
      anesthesia. The second session will be started before a conscious patient will be transported&#xD;
      from intensive care unit to general ward.&#xD;
&#xD;
      All the measurements will be taken in the intensive care unit at an ambient temperature of&#xD;
      21° C, after patients will give their written informed consent to participate in the study.&#xD;
      All patients will be awake, fasting and in the supine position. ABI will be measured&#xD;
      according to the guidelines issued by AHA. Systolic blood pressure will be measured using a&#xD;
      Doppler device (Echo Sounder ES-101EX, Hadeco, Japan) and a validated and calibrated aneroid&#xD;
      sphygmomanometer (Minimus II, Rister, Germany). Measurement of ABI using oscillometric method&#xD;
      will be performed using WatchBP Office ABI system (Microlife WatchBP AG, Widnau,&#xD;
      Switzerland). The appropriate cuff size will be used with the width of the cuff being at&#xD;
      least 40% of the limb circumference. The arm with higher systolic blood pressure will be used&#xD;
      to calculate the ABI. Higher systolic blood pressure measured on the posterior tibial or&#xD;
      dorsalis pedis artery will be used to calculate the ABI. During both study sessions ABI&#xD;
      measurements will be repeated 3 times with each method in the reverse order of the preceding&#xD;
      measurement e.g., in the case of the initial counterclockwise sequence: right arm, right&#xD;
      popliteal, right dorsalis pedis, left popliteal, left dorsalis pedis, left arm, right arm,&#xD;
      the clockwise sequence will be used, starting and ending with the left arm. The same sequence&#xD;
      of limb pressure measurements will be used used during the study.&#xD;
&#xD;
      A sample size calculation was based on the preliminary observations made by the study team.&#xD;
      It was calculated that the study sample size of 79 subjects would be needed to detect a&#xD;
      difference of 0.1 in the ABI measured in sinus rhythm and during atrial fibrillation, with a&#xD;
      two-tailed α of 0.05 and a (1-β) of 0.90. The investigators initial estimate of sample size&#xD;
      of 115 patients incorporated an assumption of dropout due to non-effective electrical&#xD;
      cardioversion, patient decision to quit study or failure to obtain adequate ABI.&#xD;
&#xD;
      The measurements will be repeated three times with each method and for the each method the&#xD;
      mean will be used for the calculations. Investigator - study nurse, trained at the vascular&#xD;
      department, will perform all ABI measurements.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference Between ABI (Ankle - Brachial Index) Before Electrical Cardioversion Using Two Methods (Doppler and Oscillometric).</measure>
    <time_frame>Through the study</time_frame>
    <description>3 ABI measurements using both methods (doppler and oscillometric) were performed per participant and the Mean value was considered for each participant, and then a Median value was calculated across participants.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference Between ABI Measured Before and After Electrical Cardioversion Using Doppler Method.</measure>
    <time_frame>Through the study period</time_frame>
    <description>3 ABI measurements using doppler method were performed per participant and the Mean value was considered for each participant, and then a Median value was calculated across participants</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">115</enrollment>
  <condition>Atrial Fibrillation Fluttering</condition>
  <arm_group>
    <arm_group_label>Single arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ABI measurement using both doppler and oscillometric method</intervention_name>
    <arm_group_label>Single arm</arm_group_label>
    <other_name>doppler method (Echo Sounder ES-101EX, Hadeco, Japan and Minimus II, Rister, Germany)</other_name>
    <other_name>oscillometric method (Microlife WatchBP AG, Widnau, Switzerland)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing electrical cardioversion due to atrial fibrillation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Circulatory instability&#xD;
&#xD;
          -  Use of vasoconstrictive agents&#xD;
&#xD;
          -  Limb trauma&#xD;
&#xD;
          -  Upper limb artery stenosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maciej Sinski, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Warsaw</affiliation>
  </overall_official>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <results_first_submitted>May 9, 2017</results_first_submitted>
  <results_first_submitted_qc>June 19, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">July 18, 2017</results_first_posted>
  <last_update_submitted>June 19, 2017</last_update_submitted>
  <last_update_submitted_qc>June 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Warsaw</investigator_affiliation>
    <investigator_full_name>Maciej Sinski</investigator_full_name>
    <investigator_title>M.D., Ph.D.</investigator_title>
  </responsible_party>
  <keyword>ankle - brachial index</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Raw data will be attached to manuscript.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>One hundred and fifteen consecutive patients with atrial fibrillation admitted to Department of Internal Medicine, Hypertension and Vascular Diseases, Medical University of Warsaw for electrical cardioversion were screened. Participants were recruited to the study from October 2012 up to December 2015.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Single Arm</title>
          <description>Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation&#xD;
ABI measurement using both doppler and oscillometric method</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="115"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="99"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Single Arm</title>
          <description>Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation&#xD;
ABI measurement using both doppler and oscillometric method.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="99"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.5" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="99"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Difference Between ABI (Ankle - Brachial Index) Before Electrical Cardioversion Using Two Methods (Doppler and Oscillometric).</title>
        <description>3 ABI measurements using both methods (doppler and oscillometric) were performed per participant and the Mean value was considered for each participant, and then a Median value was calculated across participants.</description>
        <time_frame>Through the study</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation&#xD;
ABI measurement using both doppler and oscillometric method</description>
          </group>
        </group_list>
        <measure>
          <title>Difference Between ABI (Ankle - Brachial Index) Before Electrical Cardioversion Using Two Methods (Doppler and Oscillometric).</title>
          <description>3 ABI measurements using both methods (doppler and oscillometric) were performed per participant and the Mean value was considered for each participant, and then a Median value was calculated across participants.</description>
          <units>ratio</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="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ABI oscillometric before</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.21" lower_limit="1.13" upper_limit="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ABI oscillometric after</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.215" lower_limit="1.140" upper_limit="1.260"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ABI doppler before</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.14" lower_limit="1.0700" upper_limit="1.2175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ABI doppler after</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.18" lower_limit="1.09" upper_limit="1.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>It was calculated that the study sample size of 79 subjects would be needed to detect a difference of 0.1 in the ABI measured in sinus rhythm and during atrial fibrillation, with a two-tailed α of 0.05 and a (1-β) of 0.90. Our initial estimate of sample size of 115 patients incorporated an assumption of dropout. Intra-observer variability was calculated using intra-class correlation coefficient.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-0.0600326</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0799661</ci_lower_limit>
            <ci_upper_limit>-0.0449876</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Difference Between ABI Measured Before and After Electrical Cardioversion Using Doppler Method.</title>
        <description>3 ABI measurements using doppler method were performed per participant and the Mean value was considered for each participant, and then a Median value was calculated across participants</description>
        <time_frame>Through the study period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation&#xD;
ABI measurement using both doppler and oscillometric method</description>
          </group>
        </group_list>
        <measure>
          <title>Difference Between ABI Measured Before and After Electrical Cardioversion Using Doppler Method.</title>
          <description>3 ABI measurements using doppler method were performed per participant and the Mean value was considered for each participant, and then a Median value was calculated across participants</description>
          <units>ratio</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="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ABI doppler before</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.14" lower_limit="1.0700" upper_limit="1.2175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ABI doppler after</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.18" lower_limit="1.09" upper_limit="1.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-0.0249837</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.039992</ci_lower_limit>
            <ci_upper_limit>-0.0100226</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>October 2012 - December 2015</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Single Arm</title>
          <description>Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation&#xD;
ABI measurement using both doppler and oscillometric method</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="99"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="99"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Jacek Lewandowski</name_or_title>
      <organization>Warsaw Medical University</organization>
      <phone>5992828 ext +48 22</phone>
      <email>jlewandowski@wum.edu.pl</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/NCT02986282
org study id: AFABI
nct id: NCT02986282
lead sponsor: 
has dmc: No
Consecutive patients with atrial fibrillation will be admitted to the hospital for electrical
      cardioversion. Ankle brachial index will be measured three times with oscillometric method
      and three times with doppler method. Two study sessions will be performed: the first before
      and the second after electrical cardioversion. The first session will be ended before
      anesthesia. The second session will be started before a conscious patient will be transported
      from intensive care unit to general ward.

      All the measurements will be taken in the intensive care unit at an ambient temperature of
      21° C, after patients will give their written informed consent to participate in the study.
      All patients will be awake, fasting and in the supine position. ABI will be measured
      according to the guidelines issued by AHA. Systolic blood pressure will be measured using a
      Doppler device (Echo Sounder ES-101EX, Hadeco, Japan) and a validated and calibrated aneroid
      sphygmomanometer (Minimus II, Rister, Germany). Measurement of ABI using oscillometric method
      will be performed using WatchBP Office ABI system (Microlife WatchBP AG, Widnau,
      Switzerland). The appropriate cuff size will be used with the width of the cuff being at
      least 40% of the limb circumference. The arm with higher systolic blood pressure will be used
      to calculate the ABI. Higher systolic blood pressure measured on the posterior tibial or
      dorsalis pedis artery will be used to calculate the ABI. During both study sessions ABI
      measurements will be repeated 3 times with each method in the reverse order of the preceding
      measurement e.g., in the case of the initial counterclockwise sequence: right arm, right
      popliteal, right dorsalis pedis, left popliteal, left dorsalis pedis, left arm, right arm,
      the clockwise sequence will be used, starting and ending with the left arm. The same sequence
      of limb pressure measurements will be used used during the study.

      A sample size calculation was based on the preliminary observations made by the study team.
      It was calculated that the study sample size of 79 subjects would be needed to detect a
      difference of 0.1 in the ABI measured in sinus rhythm and during atrial fibrillation, with a
      two-tailed α of 0.05 and a (1-β) of 0.90. The investigators initial estimate of sample size
      of 115 patients incorporated an assumption of dropout due to non-effective electrical
      cardioversion, patient decision to quit study or failure to obtain adequate ABI.

      The measurements will be repeated three times with each method and for the each method the
      mean will be used for the calculations. Investigator - study nurse, trained at the vascular
      department, will perform all ABI measurements.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Difference Between ABI (Ankle - Brachial Index) Before Electrical Cardioversion Using Two Methods (Doppler and Oscillometric).
time frame: Through the study
description: 3 ABI measurements using both methods (doppler and oscillometric) were performed per participant and the Mean value was considered for each participant, and then a Median value was calculated across participants.
measure: Difference Between ABI Measured Before and After Electrical Cardioversion Using Doppler Method.
time frame: Through the study period
description: 3 ABI measurements using doppler method were performed per participant and the Mean value was considered for each participant, and then a Median value was calculated across participants
arm group label: Single arm
arm group type: Other
description: Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation
intervention type: Device
intervention name: ABI measurement using both doppler and oscillometric method
arm group label: Single arm
other name: doppler method (Echo Sounder ES-101EX, Hadeco, Japan and Minimus II, Rister, Germany)
other name: oscillometric method (Microlife WatchBP AG, Widnau, Switzerland)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Maciej Sinski, M.D., Ph.D.
role: Principal Investigator
affiliation: Medical University of Warsaw
responsible party type: Principal Investigator
investigator affiliation: Medical University of Warsaw
investigator full name: Maciej Sinski
investigator title: M.D., Ph.D.
mesh term: Atrial Fibrillation
sharing ipd: Yes
ipd description: Raw data will be attached to manuscript.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 