<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/NCT02186314</url>
  </required_header>
  <id_info>
    <org_study_id>4381</org_study_id>
    <nct_id>NCT02186314</nct_id>
  </id_info>
  <brief_title>Effect of Right Bifocal Ventricular Cardiac Pacing on Serum Level Natriuretic Peptides in Patients With Heart Failure</brief_title>
  <official_title>Effect of Right Bifocal Ventricular Cardiac Pacing on Serum Level Natriuretic Peptides in Patients With Heart Failure and Pacemaker Indication</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Dante Pazzanese de Cardiologia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Dante Pazzanese de Cardiologia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study we will select twenty patients with chronic atrial fibrillation and ventricular&#xD;
      dysfunction with permanent cardiac pacemaker indication. We will dosage serum level&#xD;
      natriuretic peptides for comparison between conventional and bifocal cardiac pacing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The target study population will comprise patients with permanent atrial fibrillation with&#xD;
      mild or moderate myocardial dysfunction according to the American consensus echocardiography&#xD;
      and the classical indication for pacemaker by Brazilian Guidelines for Cardiac Implantable&#xD;
      Electronic Devices Guidelines and the American Heart Association. Primary goal: Assess&#xD;
      whether resynchronization achieved by bifocal right ventricle pacing has influence on serum&#xD;
      levels of natriuretic peptides and whether this could be used as a measure of success.&#xD;
      Secondary goal: To compare clinical parameters,compare electrocardiographic parameters (QRS&#xD;
      complex stimulated) in ventricular apical position and ventricular bifocal position, assess&#xD;
      quality of life by questionnaire Minnesota Living With Heart Failure. Will be implanted&#xD;
      pacemaker endocardial bifocal, with placement of a ventricular endocardial electrode in the&#xD;
      septal region and another in right ventricle apical, as adopted in the conduct of Pacemaker&#xD;
      sector under local anesthesia and sedation. After pacemaker implantation, patients will be&#xD;
      randomized in a 1:1 ratio to apical or bifocal stimulation. Patients remained in this mode of&#xD;
      stimulation for two months, after which they will be subjected to the following sequence of&#xD;
      reviews: Clinical assessment (functional classification of heart failure);assessment of&#xD;
      quality of life by the Minnesota Living With Heart Failure Questionnaire, 12-lead&#xD;
      electrocardiogram at rest, with measurements of stimulated QRS duration, evaluation of the&#xD;
      parameters of the pacemaker, serum level of peptides. At the end of this period of&#xD;
      evaluation, patients will undergo cross-over groups, those in apical ventricular pacing will&#xD;
      be allocated in the bifocal group and the last one will be allocated to apical ventricular&#xD;
      pace. Patients will be retained in the new pacing mode for two months, and at the end of this&#xD;
      period will be submitted to clinical, laboratory and assessment of pacemaker evaluation as&#xD;
      well. At the end of the study, all patients will be kept in bifocal ventricular pacing, as&#xD;
      advocated in the conduct of Pacemaker sector.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2014</start_date>
  <completion_date type="Anticipated">February 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2016</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum level of natriuretic peptides</measure>
    <time_frame>2 months</time_frame>
    <description>Assess whether resynchronization achieved by bifocal right ventricle pacing has influence on serum levels of natriuretic peptides and whether this could be used as a marker of success.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical parameters</measure>
    <time_frame>2 months</time_frame>
    <description>We will compare clinical parameters by New York Heart Association functional classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrocardiographic parameters</measure>
    <time_frame>2 months</time_frame>
    <description>We will compare electrocardiographic parameters (QRS complex stimulated) in ventricular apical position and ventricular bifocal position</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess quality of life</measure>
    <time_frame>2 months</time_frame>
    <description>We will evaluate quality of life: Minnesota Living with Heart Failure Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Apical stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pacemaker Biotronik: apical stimulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bifocal stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pacemaker Biotronik: bifocal stimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pacemaker Biotronik: apical stimulation</intervention_name>
    <description>Patients with pacemaker (Biotronik): an electrode will be implanted in the apical position of the right ventricle and an electrode implanted in the septal position of the right ventricle.The patients will remained in apical stimulation for two months, after that they will be subjected to evaluation. At the end of the evaluation, patients will undergo cross-over groups( bifocal stimulation) and patients will be kept in the new pacing mode for two months when they will be submitted to clinical, laboratory evaluation and assessment of pacemaker</description>
    <arm_group_label>Apical stimulation</arm_group_label>
    <arm_group_label>Bifocal stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pacemaker Biotronik: bifocal stimulation</intervention_name>
    <description>Patients with pacemaker (Biotronik): an electrode will be implanted in the apical position of the right ventricle and an electrode implanted in the septal position of the right ventricle.The patients will remained in bifocal stimulation for two months, after that they will be subjected to evaluation. At the end of the evaluation, patients will undergo cross-over groups( apical stimulation) and patients will be kept in the new pacing mode for two months, when they will be submitted to clinical, laboratory evaluation and assessment of pacemaker</description>
    <arm_group_label>Apical stimulation</arm_group_label>
    <arm_group_label>Bifocal stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Permanent atrial fibrillation with bradycardia and classic indication for permanent&#xD;
             pacemaker&#xD;
&#xD;
          -  mild or moderate ventricular dysfunction (35% &lt;left ventricle ejection fraction &lt;55%)&#xD;
             of any etiology&#xD;
&#xD;
          -  Signature of the free and informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  left ventricle ejection fraction &gt; 55% or ≤ 35%&#xD;
&#xD;
          -  classic indication of cardiac resynchronization therapy by Brazilian Guidelines for&#xD;
             Cardiac Implantable Electronic Devices&#xD;
&#xD;
          -  Patients with left ventricle ejection fraction ≤ 35%, with permanent atrial&#xD;
             fibrillation, heart failure with functional class III or IV despite optimal&#xD;
             pharmacological treatment and QRS&gt; 150 ms&#xD;
&#xD;
          -  Patients with left ventricle ejection fraction ≤ 35%, with permanent atrial&#xD;
             fibrillation, heart failure with functional class III or IV despite optimal&#xD;
             pharmacological treatment and QRS 120-150 ms with evidence of dyssynchrony by imaging&#xD;
             method&#xD;
&#xD;
          -  Patients with indication for pacemaker when ventricular pacing is essential, left&#xD;
             ventricle ejection fraction ≤ 35% and heart failure with functional class III or IV&#xD;
&#xD;
          -  Refusal to signing the informed consent&#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>carolina Mizzaci</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Dante Pazzanese de Cardiologia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Carolina Mizzaci</last_name>
    <phone>11 966209622</phone>
    <email>carolina.mizzaci@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Carolina Christianini Mizzaci</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>04012909</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carolina Mizzaci</last_name>
      <phone>11 966209622</phone>
      <email>carolina.mizzaci@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>June 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>August 1, 2016</last_update_submitted>
  <last_update_submitted_qc>August 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 3, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Dante Pazzanese de Cardiologia</investigator_affiliation>
    <investigator_full_name>Carolina Crhistianini Mizzaci</investigator_full_name>
    <investigator_title>Effect of right bifocal cardiac ventricular pacing on serum level natriuretic peptides in patients with heart failure and pacemaker indication</investigator_title>
  </responsible_party>
  <keyword>atrial fibrillation, heart failure, pacemaker</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</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/NCT02186314
org study id: 4381
nct id: NCT02186314
lead sponsor: 
has dmc: No
In this study we will select twenty patients with chronic atrial fibrillation and ventricular
      dysfunction with permanent cardiac pacemaker indication. We will dosage serum level
      natriuretic peptides for comparison between conventional and bifocal cardiac pacing.
The target study population will comprise patients with permanent atrial fibrillation with
      mild or moderate myocardial dysfunction according to the American consensus echocardiography
      and the classical indication for pacemaker by Brazilian Guidelines for Cardiac Implantable
      Electronic Devices Guidelines and the American Heart Association. Primary goal: Assess
      whether resynchronization achieved by bifocal right ventricle pacing has influence on serum
      levels of natriuretic peptides and whether this could be used as a measure of success.
      Secondary goal: To compare clinical parameters,compare electrocardiographic parameters (QRS
      complex stimulated) in ventricular apical position and ventricular bifocal position, assess
      quality of life by questionnaire Minnesota Living With Heart Failure. Will be implanted
      pacemaker endocardial bifocal, with placement of a ventricular endocardial electrode in the
      septal region and another in right ventricle apical, as adopted in the conduct of Pacemaker
      sector under local anesthesia and sedation. After pacemaker implantation, patients will be
      randomized in a 1:1 ratio to apical or bifocal stimulation. Patients remained in this mode of
      stimulation for two months, after which they will be subjected to the following sequence of
      reviews: Clinical assessment (functional classification of heart failure);assessment of
      quality of life by the Minnesota Living With Heart Failure Questionnaire, 12-lead
      electrocardiogram at rest, with measurements of stimulated QRS duration, evaluation of the
      parameters of the pacemaker, serum level of peptides. At the end of this period of
      evaluation, patients will undergo cross-over groups, those in apical ventricular pacing will
      be allocated in the bifocal group and the last one will be allocated to apical ventricular
      pace. Patients will be retained in the new pacing mode for two months, and at the end of this
      period will be submitted to clinical, laboratory and assessment of pacemaker evaluation as
      well. At the end of the study, all patients will be kept in bifocal ventricular pacing, as
      advocated in the conduct of Pacemaker sector.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Serum level of natriuretic peptides
time frame: 2 months
description: Assess whether resynchronization achieved by bifocal right ventricle pacing has influence on serum levels of natriuretic peptides and whether this could be used as a marker of success.
measure: Clinical parameters
time frame: 2 months
description: We will compare clinical parameters by New York Heart Association functional classification
measure: Electrocardiographic parameters
time frame: 2 months
description: We will compare electrocardiographic parameters (QRS complex stimulated) in ventricular apical position and ventricular bifocal position
measure: Assess quality of life
time frame: 2 months
description: We will evaluate quality of life: Minnesota Living with Heart Failure Questionnaire
arm group label: Apical stimulation
arm group type: Active Comparator
description: Pacemaker Biotronik: apical stimulation
arm group label: Bifocal stimulation
arm group type: Active Comparator
description: Pacemaker Biotronik: bifocal stimulation
intervention type: Device
intervention name: Pacemaker Biotronik: apical stimulation
description: Patients with pacemaker (Biotronik): an electrode will be implanted in the apical position of the right ventricle and an electrode implanted in the septal position of the right ventricle.The patients will remained in apical stimulation for two months, after that they will be subjected to evaluation. At the end of the evaluation, patients will undergo cross-over groups( bifocal stimulation) and patients will be kept in the new pacing mode for two months when they will be submitted to clinical, laboratory evaluation and assessment of pacemaker
arm group label: Apical stimulation
arm group label: Bifocal stimulation
intervention type: Device
intervention name: Pacemaker Biotronik: bifocal stimulation
description: Patients with pacemaker (Biotronik): an electrode will be implanted in the apical position of the right ventricle and an electrode implanted in the septal position of the right ventricle.The patients will remained in bifocal stimulation for two months, after that they will be subjected to evaluation. At the end of the evaluation, patients will undergo cross-over groups( apical stimulation) and patients will be kept in the new pacing mode for two months, when they will be submitted to clinical, laboratory evaluation and assessment of pacemaker
arm group label: Apical stimulation
arm group label: Bifocal stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: carolina Mizzaci
role: Principal Investigator
affiliation: Instituto Dante Pazzanese de Cardiologia
last name: Carolina Mizzaci
phone: 11 966209622
email: carolina.mizzaci@hotmail.com
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Instituto Dante Pazzanese de Cardiologia
investigator full name: Carolina Crhistianini Mizzaci
investigator title: Effect of right bifocal cardiac ventricular pacing on serum level natriuretic peptides in patients with heart failure and pacemaker indication
mesh term: Heart Failure