<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/NCT03305393</url>
  </required_header>
  <id_info>
    <org_study_id>IMPROVE RESPONSE</org_study_id>
    <nct_id>NCT03305393</nct_id>
  </id_info>
  <brief_title>Implementation of a Protocol Utilizing Adaptive CRT in a Normal AV Conduction, CRT Non-Response Population at Generator Replacement</brief_title>
  <official_title>Implementation of a Protocol Utilizing Adaptive CRT in a Normal AV Conduction, CRT Non-Response Population at Generator Replacement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stern Cardiovascular Foundation, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stern Cardiovascular Foundation, Inc.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      IMPROVE RESPONSE is a physician initiated research study. It is a prospective,&#xD;
      non-randomized, multi-center, post-market, U.S. Cardiac Resynchronization Therapy (CRT) in&#xD;
      heart failure (HF) observational study. The purpose of this clinical study is to test the&#xD;
      hypothesis that market-released CRT devices, which contain the AdaptivCRT (aCRT) algorithm&#xD;
      have an incremental benefit in improving CRT response in a chronic CRT non responder&#xD;
      population with left bundle branch block (LBBB) and normal atrio-ventricular (AV) condition&#xD;
      compared to CRT devices with traditional biventricular pacing delivery methods at generator&#xD;
      replacement.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Only one subject was enrolled and that subject was Lost to Follow Up. Decision was made to&#xD;
    terminate the study.&#xD;
  </why_stopped>
  <start_date type="Actual">June 11, 2017</start_date>
  <completion_date type="Actual">July 3, 2018</completion_date>
  <primary_completion_date type="Actual">July 3, 2018</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>Ejection fraction</measure>
    <time_frame>12 Months</time_frame>
    <description>Change in ejection fraction as determined by echocardiography 6 months following the addition of adaptive CRT as compared to the same end points following patient management optimization</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NYHA functional class</measure>
    <time_frame>12 months</time_frame>
    <description>Change in NYHA functional class 6 months following the addition of adaptive CRT as compared to the same end points following patient management optimization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Atrial fibrillation burden</measure>
    <time_frame>12 Months</time_frame>
    <description>Atrial fibrillation burden and/or progression to permanent atrial fibrillation as determined by device interrogation and review</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart failure hospitalizations</measure>
    <time_frame>12 months</time_frame>
    <description>Amount and severity of heart failure hospitalizations and health care utilization as reported by subjects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left ventricular end systolic volume</measure>
    <time_frame>12 months</time_frame>
    <description>As determined by echocardiographic evidence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first appropriate therapy for VT and/or VF</measure>
    <time_frame>12 months</time_frame>
    <description>Time determined by device interrogation from sensing to response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of RV synchronized LV pacing</measure>
    <time_frame>12 months</time_frame>
    <description>Percentage determined by device interrogation and compared to clinical outcomes</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Adaptiv CRT</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Adaptiv CRT algorithm in Medtronic FDA approved CRT devices to be programmed as ON at 6 month follow-up visit</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Adaptiv CRT</intervention_name>
    <description>Adaptiv CRT algorithm to be programmed to ON in CRT devices of study patients at 6 month follow-up visit</description>
    <arm_group_label>Adaptiv CRT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal AV conduction (SAV&lt;220 ms or PAV&lt;270 MS)&#xD;
&#xD;
          -  Left Bundle Branch Block (defined as &gt; or = to 140 ms (male) or &gt; or = 130 (female),&#xD;
             QR or rS in leads V1 and V2, and Mid QRS notching or slurring in v 2 of leads V1, V2,&#xD;
             V5, V6 and I and aVL.)&#xD;
&#xD;
          -  Patient and/or physician assessment or unchanged or worsened heart failure status at&#xD;
             the time of recommended replacement time (RRT) for previous CRT device.&#xD;
&#xD;
          -  Sinus Rhythm at the time of enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Moderate to severe Aortic Stenosis&#xD;
&#xD;
          -  Moderate to severe Mitral Regurgitation&#xD;
&#xD;
          -  Patient age &lt;18 years old&#xD;
&#xD;
          -  AF burden &gt;15%&#xD;
&#xD;
          -  Severe pulmonary disease requiring supplemental oxygen use&#xD;
&#xD;
          -  ESRD&#xD;
&#xD;
          -  System Modification at RRT Generator Changeout&#xD;
&#xD;
          -  AdaptivCRT prior to enrollment&#xD;
&#xD;
          -  Expected patient longevity &lt; 1 year&#xD;
&#xD;
          -  Persistant or chronic atrial fibriliation&#xD;
&#xD;
          -  Women who are pregnant or who plan to become pregnant during the clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Stern Cardiovascular Foundation</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>September 17, 2019</last_update_submitted>
  <last_update_submitted_qc>September 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Heart Failure</keyword>
  <keyword>CRT</keyword>
  <keyword>Cardiac Recynchronization Therapy</keyword>
  <keyword>left bundle branch block</keyword>
  <keyword>atrio-ventricular conduction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03305393
org study id: IMPROVE RESPONSE
nct id: NCT03305393
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
IMPROVE RESPONSE is a physician initiated research study. It is a prospective,
      non-randomized, multi-center, post-market, U.S. Cardiac Resynchronization Therapy (CRT) in
      heart failure (HF) observational study. The purpose of this clinical study is to test the
      hypothesis that market-released CRT devices, which contain the AdaptivCRT (aCRT) algorithm
      have an incremental benefit in improving CRT response in a chronic CRT non responder
      population with left bundle branch block (LBBB) and normal atrio-ventricular (AV) condition
      compared to CRT devices with traditional biventricular pacing delivery methods at generator
      replacement.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Ejection fraction
time frame: 12 Months
description: Change in ejection fraction as determined by echocardiography 6 months following the addition of adaptive CRT as compared to the same end points following patient management optimization
measure: NYHA functional class
time frame: 12 months
description: Change in NYHA functional class 6 months following the addition of adaptive CRT as compared to the same end points following patient management optimization
measure: Atrial fibrillation burden
time frame: 12 Months
description: Atrial fibrillation burden and/or progression to permanent atrial fibrillation as determined by device interrogation and review
measure: Heart failure hospitalizations
time frame: 12 months
description: Amount and severity of heart failure hospitalizations and health care utilization as reported by subjects
measure: Left ventricular end systolic volume
time frame: 12 months
description: As determined by echocardiographic evidence
measure: Time to first appropriate therapy for VT and/or VF
time frame: 12 months
description: Time determined by device interrogation from sensing to response
measure: Percentage of RV synchronized LV pacing
time frame: 12 months
description: Percentage determined by device interrogation and compared to clinical outcomes
arm group label: Adaptiv CRT
arm group type: Other
description: Adaptiv CRT algorithm in Medtronic FDA approved CRT devices to be programmed as ON at 6 month follow-up visit
intervention type: Device
intervention name: Adaptiv CRT
description: Adaptiv CRT algorithm to be programmed to ON in CRT devices of study patients at 6 month follow-up visit
arm group label: Adaptiv CRT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No