<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/NCT03268707</url>
  </required_header>
  <id_info>
    <org_study_id>PV5361</org_study_id>
    <nct_id>NCT03268707</nct_id>
  </id_info>
  <brief_title>Influence of an Innovative Telemetric Smartphone Application on Re-hospitalization</brief_title>
  <acronym>TRACE-AF</acronym>
  <official_title>Influence of an Innovative Telemetric Smartphone Application on Re-hospitalization And Quality of Life After Cryoballoon Pulmonary vEin Isolation in Patients With Paroxysmal Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitätsklinikum Hamburg-Eppendorf</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>
      A randomized, open, mono-centric pilot study to investigate the influence of an innovative&#xD;
      telemetric smartphone application on re-hospitalization and quality of life after cryoballoon&#xD;
      pulmonary vein isolation in patients with paroxysmal atrial fibrillation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The telemetric smartphone application includes a digitized medical record, a mobile ECG&#xD;
      device and a 24-hour on call service by a cardiologist. The hypothesis is that the use of a&#xD;
      telemetric smartphone application can reduce re-hospitalization in patients after cryoballoon&#xD;
      pulmonary vein isolation. Secondary endpoints are quality of life measurements, health care&#xD;
      cost calculations and recurrences of atrial fibrillation after ablation. All patients will&#xD;
      undergo ablation and will be randomized into two groups: 1) conventional follow up with&#xD;
      outpatient visits 6 and 12 months after ablation compared to 2) a structured follow up with&#xD;
      the smartphone application, a mobile ECG device (patients will be able to send in as many&#xD;
      ECGs as wanted), up to three phone calls with a cardiologist (24-hour on call service) as&#xD;
      well as outpatient visits 6 and 12 months after cryo-ablation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 15, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>Sequential Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rehospitalization Recurrence of AF</measure>
    <time_frame>in 12 months follow up</time_frame>
    <description>Rate of rehospitalization after cryoballoon pulmonary vein isolation in patients with paroxysmal atrial fibrillation, Recurrence of sustained atrial fibrillation (&gt;30 seconds) after atrial fibrillation ablation</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Paroxysmal Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Conventional follow up</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Conventional follow up at physician practice</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telemetric smartphone application</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Structured follow up with a telemetric smartphone application</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Telemetric smartphone application</intervention_name>
    <description>Structured follow up with a telemetric smartphone application</description>
    <arm_group_label>Telemetric smartphone application</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional follow up</intervention_name>
    <description>Conventional follow up at physician practice</description>
    <arm_group_label>Conventional follow up</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  symptomatic paroxysmal atrial fibrillation (at least two episodes within 3 months&#xD;
             prior to ablation)&#xD;
&#xD;
          -  cryoballoon pulmonary vein isolation&#xD;
&#xD;
          -  possession of a compatible smartphone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  persistent or permanent atrial fibrillation (AF)&#xD;
&#xD;
          -  prior catheter or surgical ablation of AF&#xD;
&#xD;
          -  pregnant females&#xD;
&#xD;
          -  contraindication for oral anticoagulation&#xD;
&#xD;
          -  manifest hyper-/hypothyroidism&#xD;
&#xD;
          -  no intention to cooperate&#xD;
&#xD;
          -  alcoholism&#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>Christian Meyer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitaeres Herzzentrum Hamburg GmbH</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Melanie Gunawardene, MD</last_name>
    <phone>004940741054120</phone>
    <email>m.gunawardene@uke.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Christian Meyer, MD</last_name>
    <phone>004940741054120</phone>
    <email>chr.meyer@uke.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Asklepios St Georg</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Stephan Willems</last_name>
      <phone>49 40 181885-3034</phone>
      <email>s.willems@asklepios.com</email>
    </contact>
    <contact_backup>
      <last_name>Kai Jaquet</last_name>
      <phone>49 40 181885-3034</phone>
      <email>k.jaquet@asklepios.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melanie Gunawardene</last_name>
      <phone>40741059471</phone>
      <email>m.gunawardene@uke.de</email>
    </contact>
    <contact_backup>
      <last_name>Christian Meyer</last_name>
      <phone>40741059471</phone>
      <email>chr.meyer@uke.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>June 15, 2019</last_update_submitted>
  <last_update_submitted_qc>June 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Paroxysmal Atrial Fibrillation</keyword>
  <keyword>Pulmonary Vein Isolation</keyword>
  <keyword>Telemetry Monitoring</keyword>
  <keyword>Cryoballoon ablation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <!-- 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/NCT03268707
org study id: PV5361
nct id: NCT03268707
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A randomized, open, mono-centric pilot study to investigate the influence of an innovative
      telemetric smartphone application on re-hospitalization and quality of life after cryoballoon
      pulmonary vein isolation in patients with paroxysmal atrial fibrillation.
The telemetric smartphone application includes a digitized medical record, a mobile ECG
      device and a 24-hour on call service by a cardiologist. The hypothesis is that the use of a
      telemetric smartphone application can reduce re-hospitalization in patients after cryoballoon
      pulmonary vein isolation. Secondary endpoints are quality of life measurements, health care
      cost calculations and recurrences of atrial fibrillation after ablation. All patients will
      undergo ablation and will be randomized into two groups: 1) conventional follow up with
      outpatient visits 6 and 12 months after ablation compared to 2) a structured follow up with
      the smartphone application, a mobile ECG device (patients will be able to send in as many
      ECGs as wanted), up to three phone calls with a cardiologist (24-hour on call service) as
      well as outpatient visits 6 and 12 months after cryo-ablation.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Other
masking: None (Open Label)
measure: Rehospitalization Recurrence of AF
time frame: in 12 months follow up
description: Rate of rehospitalization after cryoballoon pulmonary vein isolation in patients with paroxysmal atrial fibrillation, Recurrence of sustained atrial fibrillation (>30 seconds) after atrial fibrillation ablation
arm group label: Conventional follow up
arm group type: Other
description: Conventional follow up at physician practice
arm group label: Telemetric smartphone application
arm group type: Experimental
description: Structured follow up with a telemetric smartphone application
intervention type: Device
intervention name: Telemetric smartphone application
description: Structured follow up with a telemetric smartphone application
arm group label: Telemetric smartphone application
intervention type: Other
intervention name: Conventional follow up
description: Conventional follow up at physician practice
arm group label: Conventional follow up
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christian Meyer, MD
role: Principal Investigator
affiliation: Universitaeres Herzzentrum Hamburg GmbH
last name: Melanie Gunawardene, MD
phone: 004940741054120
email: m.gunawardene@uke.de
last name: Christian Meyer, MD
phone: 004940741054120
email: chr.meyer@uke.de
facility: 
status: Not yet recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
responsible party type: Sponsor
mesh term: Atrial Fibrillation