<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/NCT01717469</url>
  </required_header>
  <id_info>
    <org_study_id>CAAE 00610412.2.0000.0068</org_study_id>
    <nct_id>NCT01717469</nct_id>
  </id_info>
  <brief_title>Safety and the Effects of Isolated Left Ventricular Pacing in Patients With Bradyarrhythmias</brief_title>
  <acronym>SAFE-LVPACE</acronym>
  <official_title>Randomized Clinical Study to Assess the Safety and the Effects of Isolated Left Ventricular Pacing in Patients With Bradyarrhythmias</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Previous experimental and clinical studies have consistently suggested that right ventricular&#xD;
      (RV) apical pacing has important adverse effects. Ventricular pacing, however, is required,&#xD;
      and cannot be reduced in many patients with atrioventricular block. The SAFE-LVPACE study is&#xD;
      a randomized controlled trial that compare the effects of conventional right ventricular (RV)&#xD;
      pacing vs. left ventricular (LV) in patients with AV block.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Over the past several years, there has been growing concern over the significant deleterious&#xD;
      effects of RV pacing, including electromechanical dyssynchrony, proarrhythmia and development&#xD;
      of heart failure (HF). However, it remains unclear whether pacing-related ventricular&#xD;
      dyssynchrony can translate into significant LV structural changes and produce important&#xD;
      clinical impairment in an average pacemaker population with compromised AV conduction.&#xD;
      Alternatively, left ventricular pacing has been shown to minimize ventricular dyssynchrony&#xD;
      and to improve symptoms and prognosis in patients with mild to moderated systolic HF and&#xD;
      prolonged QRS duration.&#xD;
&#xD;
      This randomized controlled study is been conducted to compare the effects of conventional&#xD;
      right ventricular (RV) pacing vs. left ventricular (LV) in patients with AV block. The&#xD;
      hypothesis is that isolated LV pacing through the coronary sinus can be used safely and&#xD;
      provide greater hemodynamic benefits to patients with AV block and normal ventricular&#xD;
      function who require only the correction of heart rate.&#xD;
&#xD;
      Specifically, the investigator aims are to evaluate the safety, efficacy and the effects of&#xD;
      left ventricular pacing using active-fixation coronary sinus lead-the Attain StarFix® Model&#xD;
      4195 OTW Lead, compared to right ventricular pacing in patients with implantation criteria&#xD;
      for conventional pacemaker stimulation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2012</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2015</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Surgical success</measure>
    <time_frame>Participants will be evaluated during the perioperative period and during the hospital stay, an expected average of 2 days</time_frame>
    <description>Surgical success: absence of complications</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Echocardiographic and Clinical composite</measure>
    <time_frame>Participants will be evaluated at 6 and 24 months after PM implantation</time_frame>
    <description>Echocardiographic: ventricular dysfunction Clinical composite: all mortality, cardiovascular mortality, hospitalization, heart failure</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Quality of Life</measure>
    <time_frame>Participants will be evaluated at 6 and 24 months after PM implantation</time_frame>
    <description>Quality of life: improvement on quality of life scores measured by three questionnaires: 36-Item Short Form Health Survey (SF-36), a disease specific questionnaire for pacemaker patients (Aquarel) and Minnesota Living With Heart Failure (MLWHF).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Bradyarrhythmias</condition>
  <condition>Arrhythmias</condition>
  <condition>Atrioventricular Block</condition>
  <condition>Ventricular Dysfunction</condition>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>RV Pacing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Right ventricular pacing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LV Pacing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Left ventricular pacing through coronary sinus tributaries</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Left ventricular pacing through coronary sinus tributaries (Attain StarFix)</intervention_name>
    <description>Left ventricular pacing in patients with bradycardia</description>
    <arm_group_label>LV Pacing</arm_group_label>
    <other_name>Attain StarFix® Model 4195 OTW Lead</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Right ventricular pacing (Medtronic)</intervention_name>
    <description>Conventional right ventricular pacing in patients with bradycardia.</description>
    <arm_group_label>RV Pacing</arm_group_label>
    <other_name>Right ventricular lead Medtronic 5076-58</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Older than 18 years&#xD;
&#xD;
          -  Pacemaker initial implant by transvenous approach&#xD;
&#xD;
          -  Presence of AV block&#xD;
&#xD;
          -  Presence of atrial fibrillation / atrial flutter with slow ventricular response&#xD;
&#xD;
          -  Left ventricular systolic function &gt; 0.40&#xD;
&#xD;
          -  Subject agreed to participate and signed the consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absence of venous access&#xD;
&#xD;
          -  Impediment of venous access due to presence of intracardiac defects&#xD;
&#xD;
          -  Impediment of venous access due to presence of tricuspid valve prosthesis&#xD;
&#xD;
          -  Need for radiotherapy in the chest&#xD;
&#xD;
          -  Presence of chest deformity&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Life expectancy of less than one year&#xD;
&#xD;
          -  Contraindication to administration of iodinated contrast (creatinine &gt; 3.0) Unable to&#xD;
             attend the follow-up appointments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roberto Costa, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Roberto Costa, MD PhD</last_name>
    <phone>55-11-2661</phone>
    <phone_ext>5284</phone_ext>
    <email>rcosta@incor.usp.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Katia R Silva, RN PhD</last_name>
    <phone>9195978619</phone>
    <email>katia.research@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05403-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robeto Costa, MD PhD</last_name>
      <phone>55-11-2661</phone>
      <phone_ext>5284</phone_ext>
      <email>rcosta@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Katia R Silva, RN PhD</last_name>
      <phone>9195978619</phone>
      <email>katia.research@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Roberto Costa, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Elizabeth S Crevelari, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Katia R Silva, RN, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Caio MM Albertini, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marianna S Lacerda, RN</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Martino Martinelli Filho, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Wagner T Tamaki, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Roberto M Oliveira Jr, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Wilson Mathias Jr, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Silvana AD Nishioka, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Irapuan M Penteado, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>September 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>November 5, 2012</last_update_submitted>
  <last_update_submitted_qc>November 5, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 6, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Roberto Costa</investigator_full_name>
    <investigator_title>Associated Professor of Cardiovascular Surgery, MD PhD</investigator_title>
  </responsible_party>
  <keyword>Pacemaker</keyword>
  <keyword>Pacemaker implantation</keyword>
  <keyword>Coronary sinus</keyword>
  <keyword>Ventricular dysfunction</keyword>
  <keyword>Right ventricular pacing</keyword>
  <keyword>Left ventricular pacing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Ventricular Dysfunction</mesh_term>
    <mesh_term>Atrioventricular Block</mesh_term>
    <mesh_term>Bradycardia</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/NCT01717469
org study id: CAAE 00610412.2.0000.0068
nct id: NCT01717469
lead sponsor: 
collaborator: 
has dmc: Yes
Previous experimental and clinical studies have consistently suggested that right ventricular
      (RV) apical pacing has important adverse effects. Ventricular pacing, however, is required,
      and cannot be reduced in many patients with atrioventricular block. The SAFE-LVPACE study is
      a randomized controlled trial that compare the effects of conventional right ventricular (RV)
      pacing vs. left ventricular (LV) in patients with AV block.
Over the past several years, there has been growing concern over the significant deleterious
      effects of RV pacing, including electromechanical dyssynchrony, proarrhythmia and development
      of heart failure (HF). However, it remains unclear whether pacing-related ventricular
      dyssynchrony can translate into significant LV structural changes and produce important
      clinical impairment in an average pacemaker population with compromised AV conduction.
      Alternatively, left ventricular pacing has been shown to minimize ventricular dyssynchrony
      and to improve symptoms and prognosis in patients with mild to moderated systolic HF and
      prolonged QRS duration.

      This randomized controlled study is been conducted to compare the effects of conventional
      right ventricular (RV) pacing vs. left ventricular (LV) in patients with AV block. The
      hypothesis is that isolated LV pacing through the coronary sinus can be used safely and
      provide greater hemodynamic benefits to patients with AV block and normal ventricular
      function who require only the correction of heart rate.

      Specifically, the investigator aims are to evaluate the safety, efficacy and the effects of
      left ventricular pacing using active-fixation coronary sinus lead-the Attain StarFix® Model
      4195 OTW Lead, compared to right ventricular pacing in patients with implantation criteria
      for conventional pacemaker stimulation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Surgical success
time frame: Participants will be evaluated during the perioperative period and during the hospital stay, an expected average of 2 days
description: Surgical success: absence of complications
measure: Echocardiographic and Clinical composite
time frame: Participants will be evaluated at 6 and 24 months after PM implantation
description: Echocardiographic: ventricular dysfunction Clinical composite: all mortality, cardiovascular mortality, hospitalization, heart failure
measure: Quality of Life
time frame: Participants will be evaluated at 6 and 24 months after PM implantation
description: Quality of life: improvement on quality of life scores measured by three questionnaires: 36-Item Short Form Health Survey (SF-36), a disease specific questionnaire for pacemaker patients (Aquarel) and Minnesota Living With Heart Failure (MLWHF).
arm group label: RV Pacing
arm group type: Active Comparator
description: Right ventricular pacing
arm group label: LV Pacing
arm group type: Experimental
description: Left ventricular pacing through coronary sinus tributaries
intervention type: Device
intervention name: Left ventricular pacing through coronary sinus tributaries (Attain StarFix)
description: Left ventricular pacing in patients with bradycardia
arm group label: LV Pacing
other name: Attain StarFix® Model 4195 OTW Lead
intervention type: Device
intervention name: Right ventricular pacing (Medtronic)
description: Conventional right ventricular pacing in patients with bradycardia.
arm group label: RV Pacing
other name: Right ventricular lead Medtronic 5076-58
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Roberto Costa, MD PhD
role: Principal Investigator
affiliation: University of Sao Paulo
last name: Roberto Costa, MD PhD
phone: 55-11-2661
phone ext: 5284
email: rcosta@incor.usp.br
last name: Katia R Silva, RN PhD
phone: 9195978619
email: katia.research@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Roberto Costa
investigator title: Associated Professor of Cardiovascular Surgery, MD PhD
mesh term: Cardiovascular Diseases
mesh term: Ventricular Dysfunction
mesh term: Atrioventricular Block
mesh term: Bradycardia