<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/NCT01682239</url>
  </required_header>
  <id_info>
    <org_study_id>EC 023/2012</org_study_id>
    <nct_id>NCT01682239</nct_id>
  </id_info>
  <brief_title>Effects of Right Ventricular Pacemaker Lead Position Assessed by MRI</brief_title>
  <official_title>Effects of Different Right Ventricular Lead Positioning on Cardiac Contraction Measured by Cardiac MRI: a Pilot Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic right ventricular apical pacing has been associated with negative hemodynamic&#xD;
      effects. Clinical outcome of right ventricular pacing can be influenced by multiple factors.&#xD;
      An important factor seems to be optimal lead positioning. Data regarding left ventricular&#xD;
      function impaired by lead positioning is insufficient. The aim of the present study therefore&#xD;
      is to compare right ventricular apical pacing (RVAP) with right ventricular septal pacing&#xD;
      (RVSP). Outcome measurements are echocardiographic features, magnetic resonance imaging and&#xD;
      clinical outcome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">August 2015</completion_date>
  <primary_completion_date type="Anticipated">August 2014</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>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ejection Fraction</measure>
    <time_frame>6 month</time_frame>
    <description>As primary endpoint the difference of ventricular function in both groups will be taken. Therefore the Ejection Fraction is measured in cardiac MRI and Echocardiography. There may be a different development of contraction, whether the lead is placed in the ventricular apex or the ventricular septum.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Late Complication From Cardiac Pacemaker Implantation</condition>
  <arm_group>
    <arm_group_label>RVAP lead</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pacemaker lead implantation:&#xD;
Pacemaker leads will be placed in specific predefined RA and RV sites according to randomization. In this arm pacemaker leads will be placed in the RV apex. The successful lead positioning at its target location will be verified by surface ECG and by fluoroscopy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RVSP arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pacemaker lead implantation:&#xD;
Pacemaker leads will be placed in specific predefined RA and RV sites according to randomization. In this arm pacemaker leads will be placed in the RV septum. The successful lead positioning at its target location will be verified by surface ECG and by fluoroscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>RVAP</intervention_name>
    <description>In this arm pacemaker leads will be placed in the RV apex.</description>
    <arm_group_label>RVAP lead</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>RVSP</intervention_name>
    <description>In this arm pacemaker leads will be placed in the RV septum.</description>
    <arm_group_label>RVSP arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  patients with dysrhythmia requiring dual-chamber pacemaker implantation&#xD;
&#xD;
          -  planed MRI-pacemaker implantation (Accent MRI System,St. Jude Medical)&#xD;
&#xD;
          -  age between 18-90 years&#xD;
&#xD;
          -  no absolute pacemaker dependence&#xD;
&#xD;
          -  no present heart failure or any significant coronary heart disease (exclusion by&#xD;
             anamnesis and echocardiography - LVH &lt;15mm, LV EF&gt;50%)&#xD;
&#xD;
          -  no previous myocardial infarction or significant coronary artery disease&#xD;
&#xD;
          -  life expectancy &gt; 1 year&#xD;
&#xD;
          -  patients willing to participate in follow-up&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Contraindications for MRI (Brain aneurysm clips, artificial heart valves, artificial&#xD;
             joints, vascular stents)&#xD;
&#xD;
          -  Any contraindication for surgery&#xD;
&#xD;
          -  Absolute pacemaker dependence&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  GFR&lt;30ml/min/1,73m2&#xD;
&#xD;
          -  Allergy to contrast agent&#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>Alfred Kocher, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Cardiac Surgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Cardiac Surgery, MUV</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <reference>
    <citation>Beinart R, Nazarian S. MRI-Conditional Cardiac Implantable Electronic Devices: What's New and What Can We Expect in the Future? Curr Treat Options Cardiovasc Med. 2012 Oct;14(5):558-64. doi: 10.1007/s11936-012-0197-2.</citation>
    <PMID>22851216</PMID>
  </reference>
  <reference>
    <citation>Cano O, Osca J, Sancho-Tello MJ, Sanchez JM, Ortiz V, Castro JE, Salvador A, Olague J. Comparison of effectiveness of right ventricular septal pacing versus right ventricular apical pacing. Am J Cardiol. 2010 May 15;105(10):1426-32. doi: 10.1016/j.amjcard.2010.01.004. Epub 2010 Mar 30.</citation>
    <PMID>20451689</PMID>
  </reference>
  <reference>
    <citation>Inoue K, Okayama H, Nishimura K, Saito M, Yoshii T, Hiasa G, Sumimoto T, Inaba S, Suzuki J, Ogimoto A, Funada J, Higaki J. Right ventricular septal pacing preserves global left ventricular longitudinal function in comparison with apical pacing: analysis of speckle tracking echocardiography. Circ J. 2011;75(7):1609-15. doi: 10.1253/circj.cj-10-1138. Epub 2011 May 20.</citation>
    <PMID>21597204</PMID>
  </reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>September 7, 2012</last_update_submitted>
  <last_update_submitted_qc>September 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Alfred A Kocher, MD</investigator_full_name>
    <investigator_title>MD., Prof.</investigator_title>
  </responsible_party>
  <!-- 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/NCT01682239
org study id: EC 023/2012
nct id: NCT01682239
lead sponsor: 
has dmc: Yes
Chronic right ventricular apical pacing has been associated with negative hemodynamic
      effects. Clinical outcome of right ventricular pacing can be influenced by multiple factors.
      An important factor seems to be optimal lead positioning. Data regarding left ventricular
      function impaired by lead positioning is insufficient. The aim of the present study therefore
      is to compare right ventricular apical pacing (RVAP) with right ventricular septal pacing
      (RVSP). Outcome measurements are echocardiographic features, magnetic resonance imaging and
      clinical outcome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Ejection Fraction
time frame: 6 month
description: As primary endpoint the difference of ventricular function in both groups will be taken. Therefore the Ejection Fraction is measured in cardiac MRI and Echocardiography. There may be a different development of contraction, whether the lead is placed in the ventricular apex or the ventricular septum.
arm group label: RVAP lead
arm group type: Experimental
description: Pacemaker lead implantation:
Pacemaker leads will be placed in specific predefined RA and RV sites according to randomization. In this arm pacemaker leads will be placed in the RV apex. The successful lead positioning at its target location will be verified by surface ECG and by fluoroscopy.
arm group label: RVSP arm
arm group type: Experimental
description: Pacemaker lead implantation:
Pacemaker leads will be placed in specific predefined RA and RV sites according to randomization. In this arm pacemaker leads will be placed in the RV septum. The successful lead positioning at its target location will be verified by surface ECG and by fluoroscopy.
intervention type: Other
intervention name: RVAP
description: In this arm pacemaker leads will be placed in the RV apex.
arm group label: RVAP lead
intervention type: Other
intervention name: RVSP
description: In this arm pacemaker leads will be placed in the RV septum.
arm group label: RVSP arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Alfred Kocher, MD
role: Principal Investigator
affiliation: Department of Cardiac Surgery
facility: 
country: Austria
citation: Beinart R, Nazarian S. MRI-Conditional Cardiac Implantable Electronic Devices: What's New and What Can We Expect in the Future? Curr Treat Options Cardiovasc Med. 2012 Oct;14(5):558-64. doi: 10.1007/s11936-012-0197-2.
PMID: 22851216
citation: Cano O, Osca J, Sancho-Tello MJ, Sanchez JM, Ortiz V, Castro JE, Salvador A, Olague J. Comparison of effectiveness of right ventricular septal pacing versus right ventricular apical pacing. Am J Cardiol. 2010 May 15;105(10):1426-32. doi: 10.1016/j.amjcard.2010.01.004. Epub 2010 Mar 30.
PMID: 20451689
citation: Inoue K, Okayama H, Nishimura K, Saito M, Yoshii T, Hiasa G, Sumimoto T, Inaba S, Suzuki J, Ogimoto A, Funada J, Higaki J. Right ventricular septal pacing preserves global left ventricular longitudinal function in comparison with apical pacing: analysis of speckle tracking echocardiography. Circ J. 2011;75(7):1609-15. doi: 10.1253/circj.cj-10-1138. Epub 2011 May 20.
PMID: 21597204
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Alfred A Kocher, MD
investigator title: MD., Prof.