<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/NCT03795883</url>
  </required_header>
  <id_info>
    <org_study_id>RMB CTIL-0216-18</org_study_id>
    <nct_id>NCT03795883</nct_id>
  </id_info>
  <brief_title>The Thrombotic Potential of Heart Chambers in the Presence or Absence of Atrial Fibrillation.</brief_title>
  <official_title>The Thrombotic Potential (Thrombin Generation) of Left Atrium and Other Heart Chambers in Atrial Fibrillation Patients Compared to Patients Without Atrial Fibrillation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rambam Health Care Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rambam Health Care Campus</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 investigators aim to test the thrombotic potential of various heart chambers including&#xD;
      left atrium, left atrial appendage, right atrium and peripheral veins. Blood samples will be&#xD;
      taken from the different chambers in 50 patients admitted for standard pulmonary vein&#xD;
      ablation and compared to patients without atrial fibrillation admitted for left sided supra&#xD;
      ventricular tachycardia or mitral clip. Thrombin generation parameters will be assessed by&#xD;
      the calibrated automated thrombogram.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Atrial fibrillation is the most common arrhythmia, there is a strong correlation between&#xD;
      atrial fibrillation and embolic stroke. In order to lower the risk for embolic stroke&#xD;
      anticoagulation is recommended for patients with CHADS-VASC score equal or above 2. The&#xD;
      mechanism for thrombus formation in the left atrium is thought to be caused by various&#xD;
      factors 1. blood stasis due to the loss of atrial kick 2. endothelial dysfunction 3. blood&#xD;
      hemostatic alteration leading to procoagulant state.&#xD;
&#xD;
      Previous studies demonstrated increased thrombin generation in the left atrium in patients&#xD;
      with atrial fibrillation, when compared to other heart chambers and when compared to control&#xD;
      group in patients with structurally normal heart.&#xD;
&#xD;
      In recent years calibrated automated thrombogram (CAT) is considered a good indicator for&#xD;
      total thrombotic activity in hypercoagulable states.&#xD;
&#xD;
      In the current study the investigators aim to test the thrombotic potential of various heart&#xD;
      chambers including left atrium, left atrial appendage, right atrium and peripheral veins.&#xD;
      Blood samples will be taken from the different chambers in 50 patients admitted for standard&#xD;
      pulmonary vein ablation without changing the course of the procedure. Thrombin generation&#xD;
      parameters will be assessed by the calibrated automated thrombogram. A control group composed&#xD;
      of 50 patients admitted for standard left sided supra ventricular tachycardia ablation or&#xD;
      patients admitted to mitral clip procedure without the presence of atrial fibrillation.&#xD;
&#xD;
      In addition demographic data,CHADS-VASC score, atrial fibrillation burden, echocardiographic&#xD;
      and cardiac CT parameters will be collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">March 9, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</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>ETP of various heart chambers measured by the calibrated automated thrombogram (CAT)</measure>
    <time_frame>1 Day</time_frame>
    <description>ETP (endogenous thrombotic potential) nM*min</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak height of various heart chambers measured by the calibrated automated thrombogram (CAT)</measure>
    <time_frame>1 Day</time_frame>
    <description>Peak height nM</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lag time of various heart chambers measured by the calibrated automated thrombogram (CAT)</measure>
    <time_frame>1 Day</time_frame>
    <description>Lag time in minutes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to peak of various heart chambers measured by the calibrated automated thrombogram (CAT)</measure>
    <time_frame>1 Day</time_frame>
    <description>Time to peak in minutes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The 1 year incidence of thromboembolic events</measure>
    <time_frame>1 Year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of participants with spontaneous echocardiographic contrast demonstrated in trans-esophageal echocardiogram (TEE)</measure>
    <time_frame>1 Days</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">47</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Thrombosis Cardiac</condition>
  <condition>Left Atrial Thrombosis</condition>
  <arm_group>
    <arm_group_label>Participants with atrial fibrillation</arm_group_label>
    <description>Patients with atrial fibrillation admitted for standard pulmonary vein ablation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Participants without atrial fibrillation</arm_group_label>
    <description>Patients without atrial fibrillation admitted for standard left sided supra ventricular tachycardia ablation or patients admitted to mitral clip procedure.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Ten cc of blood will be collected from each heart chamber (Left atrium, Left atrial&#xD;
      appendage, Right atrium, Right ventricle) and peripheral vein&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Study group:Participants with atrial fibrillation admitted to pulmonary vein ablation&#xD;
        Control group: Participant without atrial fibrillation admitted to left sided SVT ablation&#xD;
        or Mitral clip.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age above 18&#xD;
&#xD;
          -  Pulmonary vein ablation, SVT ablation or mitral clip.&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Left atrial thrombus&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Active malignancy&#xD;
&#xD;
          -  Thrombophilia&#xD;
&#xD;
          -  Anticoagulants 24 hours before procedure&#xD;
&#xD;
          -  Active infectious disease&#xD;
&#xD;
          -  Chronic kidney disease (eGFR&lt;30)&#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>Rambam Health Care Campus</name>
      <address>
        <city>Haifa</city>
        <zip>31999</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>December 30, 2018</study_first_submitted>
  <study_first_submitted_qc>January 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>March 9, 2022</last_update_submitted>
  <last_update_submitted_qc>March 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rambam Health Care Campus</investigator_affiliation>
    <investigator_full_name>Adi Elias MD</investigator_full_name>
    <investigator_title>Resident Physician at Cardiology Department, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Thrombin generation</keyword>
  <keyword>Calibrated automated thrombogram</keyword>
  <keyword>Atrial fibrillation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03795883
org study id: RMB CTIL-0216-18
nct id: NCT03795883
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators aim to test the thrombotic potential of various heart chambers including
      left atrium, left atrial appendage, right atrium and peripheral veins. Blood samples will be
      taken from the different chambers in 50 patients admitted for standard pulmonary vein
      ablation and compared to patients without atrial fibrillation admitted for left sided supra
      ventricular tachycardia or mitral clip. Thrombin generation parameters will be assessed by
      the calibrated automated thrombogram.
Atrial fibrillation is the most common arrhythmia, there is a strong correlation between
      atrial fibrillation and embolic stroke. In order to lower the risk for embolic stroke
      anticoagulation is recommended for patients with CHADS-VASC score equal or above 2. The
      mechanism for thrombus formation in the left atrium is thought to be caused by various
      factors 1. blood stasis due to the loss of atrial kick 2. endothelial dysfunction 3. blood
      hemostatic alteration leading to procoagulant state.

      Previous studies demonstrated increased thrombin generation in the left atrium in patients
      with atrial fibrillation, when compared to other heart chambers and when compared to control
      group in patients with structurally normal heart.

      In recent years calibrated automated thrombogram (CAT) is considered a good indicator for
      total thrombotic activity in hypercoagulable states.

      In the current study the investigators aim to test the thrombotic potential of various heart
      chambers including left atrium, left atrial appendage, right atrium and peripheral veins.
      Blood samples will be taken from the different chambers in 50 patients admitted for standard
      pulmonary vein ablation without changing the course of the procedure. Thrombin generation
      parameters will be assessed by the calibrated automated thrombogram. A control group composed
      of 50 patients admitted for standard left sided supra ventricular tachycardia ablation or
      patients admitted to mitral clip procedure without the presence of atrial fibrillation.

      In addition demographic data,CHADS-VASC score, atrial fibrillation burden, echocardiographic
      and cardiac CT parameters will be collected.
observational model: Cohort
time perspective: Prospective
measure: ETP of various heart chambers measured by the calibrated automated thrombogram (CAT)
time frame: 1 Day
description: ETP (endogenous thrombotic potential) nM*min
measure: Peak height of various heart chambers measured by the calibrated automated thrombogram (CAT)
time frame: 1 Day
description: Peak height nM
measure: Lag time of various heart chambers measured by the calibrated automated thrombogram (CAT)
time frame: 1 Day
description: Lag time in minutes
measure: Time to peak of various heart chambers measured by the calibrated automated thrombogram (CAT)
time frame: 1 Day
description: Time to peak in minutes
measure: The 1 year incidence of thromboembolic events
time frame: 1 Year
measure: The number of participants with spontaneous echocardiographic contrast demonstrated in trans-esophageal echocardiogram (TEE)
time frame: 1 Days
arm group label: Participants with atrial fibrillation
description: Patients with atrial fibrillation admitted for standard pulmonary vein ablation.
arm group label: Participants without atrial fibrillation
description: Patients without atrial fibrillation admitted for standard left sided supra ventricular tachycardia ablation or patients admitted to mitral clip procedure.
Ten cc of blood will be collected from each heart chamber (Left atrium, Left atrial
      appendage, Right atrium, Right ventricle) and peripheral vein
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Rambam Health Care Campus
investigator full name: Adi Elias MD
investigator title: Resident Physician at Cardiology Department, Principal Investigator
mesh term: Atrial Fibrillation
mesh term: Thrombosis
sharing ipd: No