<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/NCT02247817</url>
  </required_header>
  <id_info>
    <org_study_id>METc 2013/387</org_study_id>
    <nct_id>NCT02247817</nct_id>
  </id_info>
  <brief_title>A Combined Transvenous and Epicardial Lead Placement Procedure for Implantation of Cardiac Resynchronization Devices: a Feasibility Study.</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Center Groningen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medical Center Groningen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cardiac resynchronization therapy has become one of the cornerstones of the treatment of&#xD;
      heart failure. However, a large proportion of patients still fails to this type of therapy.&#xD;
      This may be due to a suboptimal position of the left ventricular pacing lead, which may be&#xD;
      caused by unfavorable cardiac venous anatomy. Implantation of the pacing lead using video&#xD;
      assisted thoracic surgery is more flexible and evades the venous system altogether, resulting&#xD;
      in a much more favorable position of the pacing lead, with better treatment results as e&#xD;
      consequence.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of procedure related serious adverse events</measure>
    <time_frame>30 days after implantation of device</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Heart Failure With Intraventricular Conduction Delay</condition>
  <arm_group>
    <arm_group_label>HYBRID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hybrid transvenous/epicardial implantation of a CRT-(D) device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hybrid CRT-D/P implantation</intervention_name>
    <arm_group_label>HYBRID</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  NYHA class II-III.&#xD;
&#xD;
          -  Left ventricular ejection fraction ≤ 35%.&#xD;
&#xD;
          -  QRS-duration of ≥ 120 ms (NYHA III) or ≥ 130 ms (NYHA II) and left bundle branch block&#xD;
             morphology.&#xD;
&#xD;
          -  No sidebranch of the coronary sinus near the posterolateral wall of the left ventricle&#xD;
             and/or presence of a Thebesian valve which reduces coronary sinus diameter 50% or more&#xD;
             (corresponding to a decrease in cross sectional area of 75% or more).&#xD;
&#xD;
          -  On optimal medical therapy for heart failure, including beta-blockers, ACE-inhibitors,&#xD;
             AT2-antagonists and aldosteron antagonists.&#xD;
&#xD;
          -  Age ≥ 18 years.&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
        A potential subject who meets any of the following criteria will be excluded from&#xD;
        participation in this study:&#xD;
&#xD;
          -  Coronary ischemia or a recent myocardial infarction (&lt; 6 months).&#xD;
&#xD;
          -  Allready a CRT-device implanted.&#xD;
&#xD;
          -  Venous thrombosis without options to reach the right heart.&#xD;
&#xD;
          -  Presence of any other condition than HF with a life expectancy of &lt; 1 year.&#xD;
&#xD;
          -  History of intrathoracic surgery.&#xD;
&#xD;
          -  Presence or suspected presence of a noncompliant left lung.&#xD;
&#xD;
          -  Participation in another intervention trial.&#xD;
&#xD;
          -  Unable to understand Dutch language.&#xD;
&#xD;
          -  Pregnant women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 20, 2014</study_first_submitted>
  <study_first_submitted_qc>September 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 20, 2014</last_update_submitted>
  <last_update_submitted_qc>September 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Center Groningen</investigator_affiliation>
    <investigator_full_name>Jasper J. Schouwenburg</investigator_full_name>
    <investigator_title>Drs.</investigator_title>
  </responsible_party>
  <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/NCT02247817
org study id: METc 2013/387
nct id: NCT02247817
lead sponsor: 
has dmc: Yes
Cardiac resynchronization therapy has become one of the cornerstones of the treatment of
      heart failure. However, a large proportion of patients still fails to this type of therapy.
      This may be due to a suboptimal position of the left ventricular pacing lead, which may be
      caused by unfavorable cardiac venous anatomy. Implantation of the pacing lead using video
      assisted thoracic surgery is more flexible and evades the venous system altogether, resulting
      in a much more favorable position of the pacing lead, with better treatment results as e
      consequence.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of procedure related serious adverse events
time frame: 30 days after implantation of device
arm group label: HYBRID
arm group type: Experimental
description: Hybrid transvenous/epicardial implantation of a CRT-(D) device.
intervention type: Device
intervention name: Hybrid CRT-D/P implantation
arm group label: HYBRID
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University Medical Center Groningen
investigator full name: Jasper J. Schouwenburg
investigator title: Drs.
mesh term: Heart Failure