<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/NCT03305692</url>
  </required_header>
  <id_info>
    <org_study_id>ERP 3890</org_study_id>
    <nct_id>NCT03305692</nct_id>
  </id_info>
  <brief_title>ECG Belt vs. Echocardiographic Optimization of CRT</brief_title>
  <official_title>Optimization of New CRT Recipients: Subjects Randomized to ECG Belt or Echocardiographic Optimization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alan J. Bank, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Allina Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cardiac resynchronization therapy (CRT) has been a valuable intervention for patients with&#xD;
      systolic heart failure for over 15 years. Despite years of research, there is a still a&#xD;
      25-40% non-responder rate depending on the outcomes measured. CRT optimization is a term used&#xD;
      to describe the act of individualizing the therapy (CRT programming) for an individual&#xD;
      patient. This is not often performed, but when it is, echocardiography is utilized. Recent&#xD;
      work of body surface mapping using a novel system called the ECG Belt has shown a&#xD;
      relationship between measures of electrical dyssynchrony and acute and chronic heart pumping&#xD;
      function. This study will compare outcomes of patients randomized to either echocardiographic&#xD;
      or ECG Belt optimization of CRT devices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective randomized study designed to determine whether cardiac&#xD;
      resynchronization therapy (CRT) device programming guided by the ECG Belt (Medtronic, PLC)&#xD;
      improves echocardiographic and functional outcomes in heart failure (HF) patients. The&#xD;
      population will include patients treated with CRT for standard indications (not implanted for&#xD;
      the sole purposes of this study). The study will focus enrollment on patients who do not have&#xD;
      baseline characteristics predicting the best CRT response. Therefore the study will not&#xD;
      enroll patients having non-ischemic HF etiology, left bundle branch (LBBB) morphology, and&#xD;
      QRSd &gt; 150 ms or those previously RV paced.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 31, 2017</start_date>
  <completion_date type="Actual">August 17, 2021</completion_date>
  <primary_completion_date type="Actual">August 17, 2021</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>
    <intervention_model_description>1:1 randomization</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Individual analyzing echocardiograms (primary outcome) will not know randomization of the subject.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Echocardiographic assessment of LV function</measure>
    <time_frame>6 months post optimization</time_frame>
    <description>Change in ejection fraction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Echocardiographic assessment of LV size</measure>
    <time_frame>6 months post optimization</time_frame>
    <description>Change in left ventricular end-systolic volume</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Heart Failure, Systolic</condition>
  <arm_group>
    <arm_group_label>ECG Belt</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use ECG Belt body surface mapping system to optimize CRT programming.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Echocardiography</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use mitral inflow echocardiography to optimize CRT programming.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Optimization of CRT Device</intervention_name>
    <description>Use a body surface mapping system to quantify electrical dyssynchrony or echocardiography to quantify diastolic blood flow characteristics. Program the pacemaker to maximize the benefit of the modality the subject is randomized to.</description>
    <arm_group_label>ECG Belt</arm_group_label>
    <arm_group_label>Echocardiography</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing and able to provide informed consent for participation in the study&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Received a first-time CRT device for standard clinical indication (can be upgraded&#xD;
             from non-CRT pacemaker or defibrillator if ventricular pacing &lt; 10%)&#xD;
&#xD;
          -  Adequate echocardiographic images for EF &amp; LVESV determination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unhealed open wounds on the torso and/or a history of documented severe allergic&#xD;
             reactions from ECG electrode gel&#xD;
&#xD;
          -  Enrollment in a concurrent study that could confound the results of this study&#xD;
&#xD;
          -  Pregnant or could become pregnant within the 6 month follow-up period&#xD;
&#xD;
          -  Non-ischemic cardiomyopathy, LBBB morphology, and QRSd &gt; 150 ms&#xD;
&#xD;
          -  Dysrhythmia (AF or PVCs) that will likely result in aggregate ventricular pacing &lt; 90%&#xD;
             over the 6 month follow-up period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>110 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alan Bank, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>United Heart &amp; Vascular Clinic - Allina Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>United Heart &amp; Vascular Clinic</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>September 21, 2021</last_update_submitted>
  <last_update_submitted_qc>September 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Allina Health System</investigator_affiliation>
    <investigator_full_name>Alan J. Bank, MD</investigator_full_name>
    <investigator_title>Medical Director of Research - United Heart &amp; Vascular Clinic</investigator_title>
  </responsible_party>
  <keyword>cardiac resynchronization therapy</keyword>
  <keyword>pacing</keyword>
  <keyword>echocardiography</keyword>
  <keyword>optimization</keyword>
  <keyword>heart failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Heart Failure, Systolic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We do not plan to share IPD with other researchers.</ipd_description>
  </patient_data>
  <!-- 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/NCT03305692
org study id: ERP 3890
nct id: NCT03305692
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
Cardiac resynchronization therapy (CRT) has been a valuable intervention for patients with
      systolic heart failure for over 15 years. Despite years of research, there is a still a
      25-40% non-responder rate depending on the outcomes measured. CRT optimization is a term used
      to describe the act of individualizing the therapy (CRT programming) for an individual
      patient. This is not often performed, but when it is, echocardiography is utilized. Recent
      work of body surface mapping using a novel system called the ECG Belt has shown a
      relationship between measures of electrical dyssynchrony and acute and chronic heart pumping
      function. This study will compare outcomes of patients randomized to either echocardiographic
      or ECG Belt optimization of CRT devices.
This is a prospective randomized study designed to determine whether cardiac
      resynchronization therapy (CRT) device programming guided by the ECG Belt (Medtronic, PLC)
      improves echocardiographic and functional outcomes in heart failure (HF) patients. The
      population will include patients treated with CRT for standard indications (not implanted for
      the sole purposes of this study). The study will focus enrollment on patients who do not have
      baseline characteristics predicting the best CRT response. Therefore the study will not
      enroll patients having non-ischemic HF etiology, left bundle branch (LBBB) morphology, and
      QRSd > 150 ms or those previously RV paced.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 1:1 randomization
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Individual analyzing echocardiograms (primary outcome) will not know randomization of the subject.
measure: Echocardiographic assessment of LV function
time frame: 6 months post optimization
description: Change in ejection fraction
measure: Echocardiographic assessment of LV size
time frame: 6 months post optimization
description: Change in left ventricular end-systolic volume
arm group label: ECG Belt
arm group type: Experimental
description: Use ECG Belt body surface mapping system to optimize CRT programming.
arm group label: Echocardiography
arm group type: Experimental
description: Use mitral inflow echocardiography to optimize CRT programming.
intervention type: Diagnostic Test
intervention name: Optimization of CRT Device
description: Use a body surface mapping system to quantify electrical dyssynchrony or echocardiography to quantify diastolic blood flow characteristics. Program the pacemaker to maximize the benefit of the modality the subject is randomized to.
arm group label: ECG Belt
arm group label: Echocardiography
criteria: 
gender: All
minimum age: 18 Years
maximum age: 110 Years
healthy volunteers: No
last name: Alan Bank, MD
role: Principal Investigator
affiliation: United Heart & Vascular Clinic - Allina Health System
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Allina Health System
investigator full name: Alan J. Bank, MD
investigator title: Medical Director of Research - United Heart & Vascular Clinic
mesh term: Heart Failure
mesh term: Heart Failure, Systolic
sharing ipd: No
ipd description: We do not plan to share IPD with other researchers.