<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/NCT03037333</url>
  </required_header>
  <id_info>
    <org_study_id>PSInCor-EMERG-TV-PAC</org_study_id>
    <nct_id>NCT03037333</nct_id>
  </id_info>
  <brief_title>Analysis in the EMERGEncy Between TransVenous Cardiac PACIng Guided by Fluoroscopy Versus Echocardiogram</brief_title>
  <acronym>EMERG-TV-PAC</acronym>
  <official_title>Prospective Analysis in the EMERGEncy Between TransVenous Cardiac PACIng Guided by Fluoroscopy Versus Echocardiogram</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo General Hospital</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 lot of questions about use of temporary transvenous pacing still remain obscure and there&#xD;
      is no effective comparison between use of fluoroscopy versus electrocardiogram/echocardiogram&#xD;
      in patients with bradicardias. The aim of the study is to evaluate how long does it take to&#xD;
      start the correct cardiac stimulation with transvenous pacing in patients with bradicardias&#xD;
      comparing use of fluoroscopy versus electrocardiogram/echocardiogram and compare rates of&#xD;
      complications between two methods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately 150 subjects will be recruited over a planned recruitment period of 18 months.&#xD;
      Patients will be submitted to ecchocardiogram using Philips Envisor, and electrocardiogram&#xD;
      with Philips Healthcare PageWriter TC30.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 16, 2017</start_date>
  <completion_date type="Anticipated">August 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>all cause mortality</measure>
    <time_frame>1 week</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>infection</measure>
    <time_frame>1 week</time_frame>
    <description>Incidence of infection assessed by a clinical diagnosis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>hematoma &gt; 5 cm</measure>
    <time_frame>1 week</time_frame>
    <description>image</description>
  </primary_outcome>
  <primary_outcome>
    <measure>cardiac perforation</measure>
    <time_frame>1 week</time_frame>
    <description>Incidence of cardiac perforation assessed by a clinical diagnosis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pneumothorax</measure>
    <time_frame>1 week</time_frame>
    <description>Incidence of pneumothorax assessed by a clinical diagnosis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ventricular tachycardia</measure>
    <time_frame>1 week</time_frame>
    <description>Incidence of ventricular tachycardia assessed by an ECG test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>loss of capture</measure>
    <time_frame>1 week</time_frame>
    <description>Incidence of loss of capture assessed by an ECG test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>venous thrombosis</measure>
    <time_frame>1 week</time_frame>
    <description>Incidence of venous thrombosis assessed by an ultrasound</description>
  </primary_outcome>
  <primary_outcome>
    <measure>any complication the delays definitive pacemaker &gt; 48 hours</measure>
    <time_frame>1 week</time_frame>
    <description>clinical diagnosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to start the correct cardiac stimulation with transvenous pacing</measure>
    <time_frame>1 week</time_frame>
    <description>minutes scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rates of success</measure>
    <time_frame>1 week</time_frame>
    <description>ECG test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Bradycardia</condition>
  <arm_group>
    <arm_group_label>fluoroscopy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>ECG/ECHO</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transvenous cardiac pacing guided by fluoroscopy</intervention_name>
    <description>Transvenous cardiac estimulation</description>
    <arm_group_label>fluoroscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transvenous cardiac pacing guided by ECG/ECHO</intervention_name>
    <description>Transvenous cardiac estimulation</description>
    <arm_group_label>ECG/ECHO</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult males and females aged &gt; 18 years&#xD;
&#xD;
          -  symptomatic bradicardia&#xD;
&#xD;
          -  informed consent signed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  hemodynamic instability (pulmonary congestion / systolic arterial pressure lower than&#xD;
             90 mmHg)&#xD;
&#xD;
          -  body mass index greater than 40 kg/ m2&#xD;
&#xD;
          -  use of oral anticoagulation&#xD;
&#xD;
          -  acute coronary syndromes&#xD;
&#xD;
          -  left ventricle ejection fraction &lt; 45%&#xD;
&#xD;
          -  presence of any kind of cardiac stimulation device&#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>Alexandre Soeiro, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unidade Clínica de Emergência</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alexandre Soeiro, MD</last_name>
    <phone>55-11-2661-5299</phone>
    <phone_ext>4061</phone_ext>
    <email>alexandre.soeiro@bol.com.br</email>
  </overall_contact>
  <location>
    <facility>
      <name>Instituto do Coração - HMFMUSP</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>05.417-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexandre Soeiro, MD</last_name>
      <phone>5511-2661-5299</phone>
      <email>alexandre.soeiro@bol.com.br</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <link>
    <url>https://cardiovascularultrasound.biomedcentral.com/articles/10.1186/s12947-015-0004-9</url>
    <description>Related Info</description>
  </link>
  <results_reference>
    <citation>Esmaiel A, Hassan J, Blenkhorn F, Mardigyan V. The Use of Ultrasound to Improve Axillary Vein Access and Minimize Complications during Pacemaker Implantation. Pacing Clin Electrophysiol. 2016 May;39(5):478-82. doi: 10.1111/pace.12833. Epub 2016 Mar 23.</citation>
    <PMID>26880272</PMID>
  </results_reference>
  <results_reference>
    <citation>Reusz G, Csomos A. The role of ultrasound guidance for vascular access. Curr Opin Anaesthesiol. 2015 Dec;28(6):710-6. doi: 10.1097/ACO.0000000000000245.</citation>
    <PMID>26539789</PMID>
  </results_reference>
  <results_reference>
    <citation>Bouaziz H, Zetlaoui PJ, Pierre S, Desruennes E, Fritsch N, Jochum D, Lapostolle F, Pirotte T, Villiers S. Guidelines on the use of ultrasound guidance for vascular access. Anaesth Crit Care Pain Med. 2015 Feb;34(1):65-9. doi: 10.1016/j.accpm.2015.01.004. Epub 2015 Mar 5.</citation>
    <PMID>25829319</PMID>
  </results_reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>October 23, 2018</last_update_submitted>
  <last_update_submitted_qc>October 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>echocardiogram</keyword>
  <keyword>Electrocardiogram: Electrical Alternans</keyword>
  <keyword>fluoroscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bradycardia</mesh_term>
    <mesh_term>Emergencies</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/NCT03037333
org study id: PSInCor-EMERG-TV-PAC
nct id: NCT03037333
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A lot of questions about use of temporary transvenous pacing still remain obscure and there
      is no effective comparison between use of fluoroscopy versus electrocardiogram/echocardiogram
      in patients with bradicardias. The aim of the study is to evaluate how long does it take to
      start the correct cardiac stimulation with transvenous pacing in patients with bradicardias
      comparing use of fluoroscopy versus electrocardiogram/echocardiogram and compare rates of
      complications between two methods.
Approximately 150 subjects will be recruited over a planned recruitment period of 18 months.
      Patients will be submitted to ecchocardiogram using Philips Envisor, and electrocardiogram
      with Philips Healthcare PageWriter TC30.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: all cause mortality
time frame: 1 week
measure: infection
time frame: 1 week
description: Incidence of infection assessed by a clinical diagnosis
measure: hematoma > 5 cm
time frame: 1 week
description: image
measure: cardiac perforation
time frame: 1 week
description: Incidence of cardiac perforation assessed by a clinical diagnosis
measure: pneumothorax
time frame: 1 week
description: Incidence of pneumothorax assessed by a clinical diagnosis
measure: ventricular tachycardia
time frame: 1 week
description: Incidence of ventricular tachycardia assessed by an ECG test
measure: loss of capture
time frame: 1 week
description: Incidence of loss of capture assessed by an ECG test
measure: venous thrombosis
time frame: 1 week
description: Incidence of venous thrombosis assessed by an ultrasound
measure: any complication the delays definitive pacemaker > 48 hours
time frame: 1 week
description: clinical diagnosis
measure: Time to start the correct cardiac stimulation with transvenous pacing
time frame: 1 week
description: minutes scale
measure: rates of success
time frame: 1 week
description: ECG test
arm group label: fluoroscopy
arm group type: Other
arm group label: ECG/ECHO
arm group type: Other
intervention type: Procedure
intervention name: Transvenous cardiac pacing guided by fluoroscopy
description: Transvenous cardiac estimulation
arm group label: fluoroscopy
intervention type: Procedure
intervention name: Transvenous cardiac pacing guided by ECG/ECHO
description: Transvenous cardiac estimulation
arm group label: ECG/ECHO
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexandre Soeiro, MD
role: Principal Investigator
affiliation: Unidade Clínica de Emergência
last name: Alexandre Soeiro, MD
phone: 55-11-2661-5299
phone ext: 4061
email: alexandre.soeiro@bol.com.br
facility: 
status: Recruiting
contact: 
country: Brazil
url: https://cardiovascularultrasound.biomedcentral.com/articles/10.1186/s12947-015-0004-9
description: Related Info
citation: Esmaiel A, Hassan J, Blenkhorn F, Mardigyan V. The Use of Ultrasound to Improve Axillary Vein Access and Minimize Complications during Pacemaker Implantation. Pacing Clin Electrophysiol. 2016 May;39(5):478-82. doi: 10.1111/pace.12833. Epub 2016 Mar 23.
PMID: 26880272
citation: Reusz G, Csomos A. The role of ultrasound guidance for vascular access. Curr Opin Anaesthesiol. 2015 Dec;28(6):710-6. doi: 10.1097/ACO.0000000000000245.
PMID: 26539789
citation: Bouaziz H, Zetlaoui PJ, Pierre S, Desruennes E, Fritsch N, Jochum D, Lapostolle F, Pirotte T, Villiers S. Guidelines on the use of ultrasound guidance for vascular access. Anaesth Crit Care Pain Med. 2015 Feb;34(1):65-9. doi: 10.1016/j.accpm.2015.01.004. Epub 2015 Mar 5.
PMID: 25829319
responsible party type: Sponsor
mesh term: Bradycardia
mesh term: Emergencies
sharing ipd: No