<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/NCT04500184</url>
  </required_header>
  <id_info>
    <org_study_id>samsungmc_rehab_TTA</org_study_id>
    <nct_id>NCT04500184</nct_id>
  </id_info>
  <brief_title>Exercise-based Cardiac Rehabilitation After Thoracoscopic Ablation in Patients With Persisent Atrial Fibrillation</brief_title>
  <official_title>Can Exercise-based Cardiac Rehabilitation Increase Physical Activity in Patients Who Undergoing Totally Thoracoscopic Ablation?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</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>
      Thoracoscopic ablation is a promising treatment of persistent atrial fibrillation. However,&#xD;
      the postoperative rehabilitation is very important to prevent early recurrence of atrial&#xD;
      arrhythmia. The purpose of this study is to evaluate the efficacy of professional cardiac&#xD;
      rehabilitation in patients after thoracoscopic ablation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">May 31, 2020</completion_date>
  <primary_completion_date type="Actual">May 30, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrence of atrial fibrillation</measure>
    <time_frame>every 6 months for 1 year</time_frame>
    <description>Atrial fibrillation recurrence after surgical treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>functional recovery</measure>
    <time_frame>6 months after intervention</time_frame>
    <description>exercise capacity and international physical activity questionnaire</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">24</enrollment>
  <condition>Atrial Fibrillation, Persistent</condition>
  <condition>Cardiac Rehabilitation</condition>
  <condition>Cardiopulmonary Fitness</condition>
  <arm_group>
    <arm_group_label>Exercise group</arm_group_label>
    <description>patients who underwent cardiac rehabilitation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>patients who did not undergo cardiac rehabilitation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cardiac rehabilitation</intervention_name>
    <description>rehabilitation performed by professional trainers</description>
    <arm_group_label>Exercise group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who underwent thoracoscopic ablation were included. cardiac rehabilitation was&#xD;
        performed according to the willingness of each patients.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who underwent thoracoscopic ablation due to persisent atrial fibrillation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  below 18 years&#xD;
&#xD;
          -  over 80 years old&#xD;
&#xD;
          -  malignancy&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dong Seop Jeong, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Dong Seop Jeong</investigator_full_name>
    <investigator_title>Clinical professor</investigator_title>
  </responsible_party>
  <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/NCT04500184
org study id: samsungmc_rehab_TTA
nct id: NCT04500184
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Thoracoscopic ablation is a promising treatment of persistent atrial fibrillation. However,
      the postoperative rehabilitation is very important to prevent early recurrence of atrial
      arrhythmia. The purpose of this study is to evaluate the efficacy of professional cardiac
      rehabilitation in patients after thoracoscopic ablation.
observational model: Case-Control
time perspective: Retrospective
measure: Recurrence of atrial fibrillation
time frame: every 6 months for 1 year
description: Atrial fibrillation recurrence after surgical treatment
measure: functional recovery
time frame: 6 months after intervention
description: exercise capacity and international physical activity questionnaire
arm group label: Exercise group
description: patients who underwent cardiac rehabilitation
arm group label: Control group
description: patients who did not undergo cardiac rehabilitation
intervention type: Other
intervention name: cardiac rehabilitation
description: rehabilitation performed by professional trainers
arm group label: Exercise group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Dong Seop Jeong, PhD
role: Principal Investigator
affiliation: Samsung Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Dong Seop Jeong
investigator title: Clinical professor
mesh term: Atrial Fibrillation