<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/NCT02195843</url>
  </required_header>
  <id_info>
    <org_study_id>SA-2014-07-10</org_study_id>
    <nct_id>NCT02195843</nct_id>
  </id_info>
  <brief_title>Quadripolar Leads for the Management of Heart Failure Patients in the Middle East</brief_title>
  <acronym>QUADRA-ME</acronym>
  <official_title>Quadripolar Leads for the Management of Heart Failure Patients in the Middle East</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Abdullah International Medical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>King Abdullah International Medical Research Center</source>
  <brief_summary>
    <textblock>
      Heart failure is the most rapidly growing cardiovascular condition in developed countries.&#xD;
      Despite advances in medical therapy, patients with heart failure are at high risk for death&#xD;
      and hospitalization. Cardiac Resynchronization Therapy - defibrillators (CRT-D) are an&#xD;
      effective treatment for heart failure.&#xD;
&#xD;
      Despite the high success rate of a CRT-D implant, there is a possibility of 10% that the LV&#xD;
      lead cannot be implanted in patients undergoing a trans-venous system implantation. In this&#xD;
      case, the patients may undergo multiple procedures before a lead is successfully implanted.&#xD;
      These implant failures are not due to patient selection but rather to patients heart anatomy&#xD;
      leading to lead stability problems, phrenic nerve stimulation (also called diaphragmatic&#xD;
      stimulation) and poor electrical measurements.&#xD;
&#xD;
      The phrenic nerve is not part of the heart but runs near to this area on the way to a large&#xD;
      muscle, called diaphragm, which separates the lung space from the space containing stomach,&#xD;
      liver, kidneys and other internal organs in the abdomen. If the lead electrode is close to&#xD;
      this nerve, it can cause a small part of it to contract giving you an uncomfortable&#xD;
      hiccupping sensation.&#xD;
&#xD;
      In many patients, phrenic nerve stimulation is not identified until after the implant&#xD;
      procedure when movement and postural changes bring the LV lead into closer contact with the&#xD;
      phrenic nerve.&#xD;
&#xD;
      The investigation is performed to demonstrate the equality of performance of two different&#xD;
      modalities of optimization of the implanted device and Quartet lead, Empirical (anatomical)&#xD;
      optimization and Right Ventricle Left Ventricle (RVLV) conduction delay optimization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">August 2016</completion_date>
  <primary_completion_date type="Anticipated">August 2016</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Left Ventricular End Systolic Volume (LVESV)</measure>
    <time_frame>6 months post baseline</time_frame>
    <description>Positive Clinical response defined as % change of Left Ventricular End Systolic Volume (LVESV) at 6 months follow up, compared to baseline</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">389</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Emperical</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Anatomical optimization of device and leads</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Electrical</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Electrical optimization by RVLV Conduction Time with VectSelect</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Electrical optimization by RVLV Conduction Time with VectSelect</intervention_name>
    <description>VectSelect Quartet multivector testing is a programmer-based feature that provides centralized vector testing and programming with the flexibility to select the appropriate pacing vector to meet individual patient needs.&#xD;
The Right ventricle - Left Ventricle (RV-LV) conduction time measurement will automatically identify the RV-LV conduction time for each LV electrode .</description>
    <arm_group_label>Electrical</arm_group_label>
    <other_name>VectSelect Quartet multivector testing</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Anatomical optimization of device and leads</intervention_name>
    <description>Patients will be implanted with left ventricular leads which will be positioned most basal, most apical or midway in the left ventricle. This follows the physician's routine clinical practice and judgement.</description>
    <arm_group_label>Emperical</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Implanted device and lead (Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and SJM Quadripolar lead system)</intervention_name>
    <description>All participants will be implanted with a St Jude Medical (SJM) Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and SJM Quadripolar lead system. Patients who fulfill the criteria for CRT D implant, will be invited to participate in this clinical investigation. Patients implanted with chronic leads requiring device upgrade to CRT-D can also be enrolled in the study, provided they are receiving a CRT-D device for the first time.</description>
    <arm_group_label>Electrical</arm_group_label>
    <arm_group_label>Emperical</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patients ≥ 18 years of age&#xD;
&#xD;
          -  Patient met standard CRT-D device indications (Left Ventricular Ejection Fraction&#xD;
             (LVEF) ≤ 35%, QRS ≥ 120 ms, New York Heart Association (NYHA) Class II, III or&#xD;
             ambulatory Class IV Heart Failure (HF) symptoms with optimal recommended medical&#xD;
             therapy) and will be implanted with an St Jude Medical CRT-D&#xD;
&#xD;
          -  Patient is willing to provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with non left bundle branch block (RBBB, intraventricular delay (IVCD) Block)&#xD;
&#xD;
          -  Patient has an epicardial ventricular lead system.&#xD;
&#xD;
          -  Patient has limited intrinsic atrial activity (≤ 40 bpm).&#xD;
&#xD;
          -  Patient has persistent or permanent Atrial Fibrillation.&#xD;
&#xD;
          -  Patient's life expectancy is less than 1 year&#xD;
&#xD;
          -  Patient is pregnant.&#xD;
&#xD;
          -  Patient is dependent on IV inotropic agents.&#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>July 2014</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>July 18, 2014</last_update_submitted>
  <last_update_submitted_qc>July 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Abdullah International Medical Research Center</investigator_affiliation>
    <investigator_full_name>Abdulmohsen Al Musa'ad, MD</investigator_full_name>
    <investigator_title>Consultant Adult Cardiologist</investigator_title>
  </responsible_party>
  <keyword>CRT-D</keyword>
  <keyword>Heart Failure</keyword>
  <keyword>Middle East</keyword>
  <keyword>Quadripolar</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/NCT02195843
org study id: SA-2014-07-10
nct id: NCT02195843
lead sponsor: 
collaborator: 
Heart failure is the most rapidly growing cardiovascular condition in developed countries.
      Despite advances in medical therapy, patients with heart failure are at high risk for death
      and hospitalization. Cardiac Resynchronization Therapy - defibrillators (CRT-D) are an
      effective treatment for heart failure.

      Despite the high success rate of a CRT-D implant, there is a possibility of 10% that the LV
      lead cannot be implanted in patients undergoing a trans-venous system implantation. In this
      case, the patients may undergo multiple procedures before a lead is successfully implanted.
      These implant failures are not due to patient selection but rather to patients heart anatomy
      leading to lead stability problems, phrenic nerve stimulation (also called diaphragmatic
      stimulation) and poor electrical measurements.

      The phrenic nerve is not part of the heart but runs near to this area on the way to a large
      muscle, called diaphragm, which separates the lung space from the space containing stomach,
      liver, kidneys and other internal organs in the abdomen. If the lead electrode is close to
      this nerve, it can cause a small part of it to contract giving you an uncomfortable
      hiccupping sensation.

      In many patients, phrenic nerve stimulation is not identified until after the implant
      procedure when movement and postural changes bring the LV lead into closer contact with the
      phrenic nerve.

      The investigation is performed to demonstrate the equality of performance of two different
      modalities of optimization of the implanted device and Quartet lead, Empirical (anatomical)
      optimization and Right Ventricle Left Ventricle (RVLV) conduction delay optimization.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Left Ventricular End Systolic Volume (LVESV)
time frame: 6 months post baseline
description: Positive Clinical response defined as % change of Left Ventricular End Systolic Volume (LVESV) at 6 months follow up, compared to baseline
arm group label: Emperical
arm group type: Active Comparator
description: Anatomical optimization of device and leads
arm group label: Electrical
arm group type: Active Comparator
description: Electrical optimization by RVLV Conduction Time with VectSelect
intervention type: Other
intervention name: Electrical optimization by RVLV Conduction Time with VectSelect
description: VectSelect Quartet multivector testing is a programmer-based feature that provides centralized vector testing and programming with the flexibility to select the appropriate pacing vector to meet individual patient needs.
The Right ventricle - Left Ventricle (RV-LV) conduction time measurement will automatically identify the RV-LV conduction time for each LV electrode .
arm group label: Electrical
other name: VectSelect Quartet multivector testing
intervention type: Other
intervention name: Anatomical optimization of device and leads
description: Patients will be implanted with left ventricular leads which will be positioned most basal, most apical or midway in the left ventricle. This follows the physician's routine clinical practice and judgement.
arm group label: Emperical
intervention type: Device
intervention name: Implanted device and lead (Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and SJM Quadripolar lead system)
description: All participants will be implanted with a St Jude Medical (SJM) Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and SJM Quadripolar lead system. Patients who fulfill the criteria for CRT D implant, will be invited to participate in this clinical investigation. Patients implanted with chronic leads requiring device upgrade to CRT-D can also be enrolled in the study, provided they are receiving a CRT-D device for the first time.
arm group label: Electrical
arm group label: Emperical
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: King Abdullah International Medical Research Center
investigator full name: Abdulmohsen Al Musa'ad, MD
investigator title: Consultant Adult Cardiologist
mesh term: Heart Failure