<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/NCT03813589</url>
  </required_header>
  <id_info>
    <org_study_id>SS001</org_study_id>
    <nct_id>NCT03813589</nct_id>
  </id_info>
  <brief_title>Congestive Heart Failure and Atrial Tachyarrhythmias in Pmk Patients</brief_title>
  <acronym>SEASIDE</acronym>
  <official_title>State of congEstive heArt Failure Before the onSet of atrIal Tachyarrhythmias Detected by Implanted devicE in Pacemaker Patients (SEASIDE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>San Leonardo Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>San Leonardo Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim is to correlate relationship between congestive heart failure and onset of atrial&#xD;
      tachyarrhythmias in pacemaker patients. Both atrial events and state of congestive heart&#xD;
      failure are collected automatically by implanted device.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 19, 2019</start_date>
  <completion_date type="Anticipated">June 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate relationship between atrial tachyarrhythmias and congestive heart failure</measure>
    <time_frame>twelve months</time_frame>
    <description>Relationship between thoracic impedance variations and atrial events collected by device</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Detect optimal device programming</measure>
    <time_frame>twelve months</time_frame>
    <description>Identify useful index congestion trigger value</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Heart Failure，Congestive</condition>
  <condition>Atrial Arrhythmia</condition>
  <arm_group>
    <arm_group_label>PMK patients</arm_group_label>
    <description>Patients already implanted with double chamber pacemaker able to detect automatically congestive heart failure and collect atrial events.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients implanted with dual chamber pacemaker able to automatically detect congestive&#xD;
        heart failure and atrial tachyarrhythmias events.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Recent implant of DR pacemaker according to current guidelines&#xD;
&#xD;
          -  Sinus Rhythm at enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#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>Giovanni Russo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Leonardo Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>San Leonardo Hospital</name>
      <address>
        <city>Castellammare Di Stabia</city>
        <state>Napoli</state>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 20, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>March 24, 2021</last_update_submitted>
  <last_update_submitted_qc>March 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>San Leonardo Hospital</investigator_affiliation>
    <investigator_full_name>Giovanni Russo</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Tachycardia</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/NCT03813589
org study id: SS001
nct id: NCT03813589
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
The aim is to correlate relationship between congestive heart failure and onset of atrial
      tachyarrhythmias in pacemaker patients. Both atrial events and state of congestive heart
      failure are collected automatically by implanted device.
observational model: Cohort
time perspective: Prospective
measure: Evaluate relationship between atrial tachyarrhythmias and congestive heart failure
time frame: twelve months
description: Relationship between thoracic impedance variations and atrial events collected by device
measure: Detect optimal device programming
time frame: twelve months
description: Identify useful index congestion trigger value
arm group label: PMK patients
description: Patients already implanted with double chamber pacemaker able to detect automatically congestive heart failure and collect atrial events.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Giovanni Russo, MD
role: Principal Investigator
affiliation: San Leonardo Hospital
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: San Leonardo Hospital
investigator full name: Giovanni Russo
investigator title: MD
mesh term: Heart Failure
mesh term: Tachycardia