<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/NCT03274583</url>
  </required_header>
  <id_info>
    <org_study_id>T02/005/17</org_study_id>
    <nct_id>NCT03274583</nct_id>
  </id_info>
  <brief_title>Mobile Phone Detection of Atrial Fibrillation</brief_title>
  <acronym>MODE-AF</acronym>
  <official_title>Mobile Phone Detection of Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Turku</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Turku</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the reliability of smartphone seismocardiographic&#xD;
      detection of AF in comparison to the gold standard of continuous telemetry ECG recording.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the this case-control study, 300 patients being treated in the wards of Heart Center and&#xD;
      Department of Acute Internal Medicine of Turku University Hospital in Turku, Finland between&#xD;
      April and September 2017 were included in the study. Patients were assigned to two groups&#xD;
      according to the prevalent heart rhythm (sinus rhythm or atrial fibrillation). A smartphone&#xD;
      equipped with an inbuilt accelerometer and a gyroscope was placed on the patient's chest to&#xD;
      obtain a seismocardiographic recording. Simultaneous telemetry electrocardiography was&#xD;
      obtained to assess the reliability of seismographic rhythm recordings. Results will be&#xD;
      analyzed to describe the specificity and sensitivity of the method.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 5, 2017</start_date>
  <completion_date type="Actual">November 1, 2017</completion_date>
  <primary_completion_date type="Actual">October 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity and specificity of seismocardiography in diagnosing atrial fibrillation</measure>
    <time_frame>2017-2018</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Arrhythmia</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <description>Patients being treated in the wards of Heart Center and Acute Internal Medicine of Turku University Hospital, Turku Finland between April and September 2017 with atrial fibrillation as the prevalent rhythm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Patients being treated in the wards of Heart Center and Acute Internal Medicine of Turku University Hospital, Turku Finland between April and September 2017 with sinus rhythm as the prevalent rhythm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Smartphone seismographic recording</intervention_name>
    <description>A short recording of heart rhythm using a smartphone.</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treated in the wards of Heart Center and Acute Internal Medicine of Turku&#xD;
        University Hospital, Turku Finland between April and September 2017.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for patients with FA:&#xD;
&#xD;
          -  ≥18 years of age&#xD;
&#xD;
          -  telemetry ECG available&#xD;
&#xD;
          -  being treated in Turku University Hospital Heart Center / Acute internal medicine ward&#xD;
&#xD;
          -  atrial fibrillation&#xD;
&#xD;
        Inclusion Criteria for patients with sinus rhythm:&#xD;
&#xD;
          -  ≥18 years of age&#xD;
&#xD;
          -  telemetry ECG available&#xD;
&#xD;
          -  being treated in Turku University Hospital Heart Center / Acute internal medicine ward&#xD;
&#xD;
          -  sinus rhythm&#xD;
&#xD;
          -  gender and age matching pair in FA group&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ≤18 years of age&#xD;
&#xD;
          -  paced rhythm&#xD;
&#xD;
          -  cardioversion during preceding 7 days&#xD;
&#xD;
          -  informed consent not signed&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Turku University Hospital</name>
      <address>
        <city>Turku</city>
        <state>Länsi-Suomen Lääni</state>
        <zip>20521</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>June 28, 2019</last_update_submitted>
  <last_update_submitted_qc>June 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Turku</investigator_affiliation>
    <investigator_full_name>Juhani Airaksinen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>atrial fibrillation</keyword>
  <keyword>smartphone</keyword>
  <keyword>detection</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>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03274583
org study id: T02/005/17
nct id: NCT03274583
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the reliability of smartphone seismocardiographic
      detection of AF in comparison to the gold standard of continuous telemetry ECG recording.
In the this case-control study, 300 patients being treated in the wards of Heart Center and
      Department of Acute Internal Medicine of Turku University Hospital in Turku, Finland between
      April and September 2017 were included in the study. Patients were assigned to two groups
      according to the prevalent heart rhythm (sinus rhythm or atrial fibrillation). A smartphone
      equipped with an inbuilt accelerometer and a gyroscope was placed on the patient's chest to
      obtain a seismocardiographic recording. Simultaneous telemetry electrocardiography was
      obtained to assess the reliability of seismographic rhythm recordings. Results will be
      analyzed to describe the specificity and sensitivity of the method.
observational model: Case-Control
time perspective: Prospective
measure: Sensitivity and specificity of seismocardiography in diagnosing atrial fibrillation
time frame: 2017-2018
arm group label: Study Group
description: Patients being treated in the wards of Heart Center and Acute Internal Medicine of Turku University Hospital, Turku Finland between April and September 2017 with atrial fibrillation as the prevalent rhythm.
arm group label: Control group
description: Patients being treated in the wards of Heart Center and Acute Internal Medicine of Turku University Hospital, Turku Finland between April and September 2017 with sinus rhythm as the prevalent rhythm.
intervention type: Diagnostic Test
intervention name: Smartphone seismographic recording
description: A short recording of heart rhythm using a smartphone.
arm group label: Study Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: University of Turku
investigator full name: Juhani Airaksinen
investigator title: Professor
mesh term: Atrial Fibrillation
sharing ipd: Undecided