<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/NCT03253809</url>
  </required_header>
  <id_info>
    <org_study_id>17-650</org_study_id>
    <nct_id>NCT03253809</nct_id>
  </id_info>
  <brief_title>Survey of QRS Frequency at Various Left Ventricular Pacing Sites for Cardiac Resynchronization</brief_title>
  <official_title>Survey of QRS Frequency at Various Left Ventricular Pacing Sites for Cardiac Resynchronization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</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_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      LV pacing at various sites with recording of ECG and subsequent signal analysis at different&#xD;
      sites.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During routine cardiac resynchronization pacemaker or implantable defibrillator (ICD)&#xD;
      implantation (including de-novo and upgrade from standard device, additional pacing within 3&#xD;
      different coronary veins will be performed in combination with a previously implanted right&#xD;
      ventricular pacing or ICD lead. The resulting electrocardiogram signal will be analyzed&#xD;
      afterwards. A time-frequency analysis (TFA) of several ECG leads at each paced site will be&#xD;
      performed and compared. The results of the TFA analysis will not be used to select pacing&#xD;
      lead location in this study.&#xD;
&#xD;
      The patient will then receive the left ventricular pacing lead in the standard manner.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Issue with trial administration/conduct&#xD;
  </why_stopped>
  <start_date type="Actual">July 12, 2017</start_date>
  <completion_date type="Actual">November 2, 2021</completion_date>
  <primary_completion_date type="Actual">November 2, 2021</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>
    <intervention_model_description>Nonrandomized survey of different pacing sites in the coronary veins.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>QRS Frequency at Each Paced Location</measure>
    <time_frame>Baseline</time_frame>
    <description>Time frequency analysis performed at each location</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Cardiomyopathies</condition>
  <condition>Congestive Heart Failure</condition>
  <arm_group>
    <arm_group_label>Coronary Sinus Branch Pacing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After cannulation, pacing impulses will be delivered via a Biotronik Vision Guidewire to 3 sites (apical, mid ventricular, and basal) within each coronary sinus branch receiving venous blood from the anterior, lateral and posterior regions of the ventricle.&#xD;
ECG signals will be saved digitally for analysis</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biotronik Vision Guidewire</intervention_name>
    <description>The apical, mid ventricular and basal sites within the anterior,posterior and lateral coronary sinus branch veins will be paced.</description>
    <arm_group_label>Coronary Sinus Branch Pacing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Standard implantation for cardiac resynchronization ICD or PM implantation&#xD;
&#xD;
          -  Cardiomyopathy with LVEF &lt;35%&#xD;
&#xD;
          -  QRS duration greater than 120 msec&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Age less than 18 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark J Niebauer, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <results_first_submitted>December 3, 2021</results_first_submitted>
  <results_first_submitted_qc>February 11, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 9, 2022</results_first_posted>
  <last_update_submitted>February 11, 2022</last_update_submitted>
  <last_update_submitted_qc>February 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Cardiomyopathies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 16, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03253809/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 9, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03253809/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Coronary Sinus Branch Pacing</title>
          <description>After cannulation, pacing impulses will be delivered via a Biotronik Vision Guidewire to 3 sites (apical, mid ventricular, and basal) within each coronary sinus branch receiving venous blood from the anterior, lateral and posterior regions of the ventricle.&#xD;
ECG signals will be saved digitally for analysis&#xD;
Biotronik Vision Guidewire: The apical, mid ventricular and basal sites within the anterior,posterior and lateral coronary sinus branch veins will be paced.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Unable to obtain study related data</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Coronary Sinus Branch Pacing</title>
          <description>After cannulation, pacing impulses will be delivered via a Biotronik Vision Guidewire to 3 sites (apical, mid ventricular, and basal) within each coronary sinus branch receiving venous blood from the anterior, lateral and posterior regions of the ventricle.&#xD;
ECG signals will be saved digitally for analysis&#xD;
Biotronik Vision Guidewire: The apical, mid ventricular and basal sites within the anterior,posterior and lateral coronary sinus branch veins will be paced.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Need for implantation of a left ventricular pacing lead via the coronary sinus branch beins</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>QRS Frequency at Each Paced Location</title>
        <description>Time frequency analysis performed at each location</description>
        <time_frame>Baseline</time_frame>
        <population>Unable to collect or analyze the data. Study was not feasible.</population>
        <group_list>
          <group group_id="O1">
            <title>Coronary Sinus Branch Pacing</title>
            <description>After cannulation, pacing impulses will be delivered via a Biotronik Vision Guidewire to 3 sites (apical, mid ventricular, and basal) within each coronary sinus branch receiving venous blood from the anterior, lateral and posterior regions of the ventricle.&#xD;
ECG signals will be saved digitally for analysis&#xD;
Biotronik Vision Guidewire: The apical, mid ventricular and basal sites within the anterior,posterior and lateral coronary sinus branch veins will be paced.</description>
          </group>
        </group_list>
        <measure>
          <title>QRS Frequency at Each Paced Location</title>
          <description>Time frequency analysis performed at each location</description>
          <population>Unable to collect or analyze the data. Study was not feasible.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Day of the index procedure</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Coronary Sinus Branch Pacing</title>
          <description>After cannulation, pacing impulses will be delivered via a Biotronik Vision Guidewire to 3 sites (apical, mid ventricular, and basal) within each coronary sinus branch receiving venous blood from the anterior, lateral and posterior regions of the ventricle.&#xD;
ECG signals will be saved digitally for analysis&#xD;
Biotronik Vision Guidewire: The apical, mid ventricular and basal sites within the anterior,posterior and lateral coronary sinus branch veins will be paced.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Mark Neibauer</name_or_title>
      <organization>Cleveland Clinic</organization>
      <phone>216-444-3160</phone>
      <email>niebaum@ccf.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03253809
org study id: 17-650
nct id: NCT03253809
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
LV pacing at various sites with recording of ECG and subsequent signal analysis at different
      sites.
During routine cardiac resynchronization pacemaker or implantable defibrillator (ICD)
      implantation (including de-novo and upgrade from standard device, additional pacing within 3
      different coronary veins will be performed in combination with a previously implanted right
      ventricular pacing or ICD lead. The resulting electrocardiogram signal will be analyzed
      afterwards. A time-frequency analysis (TFA) of several ECG leads at each paced site will be
      performed and compared. The results of the TFA analysis will not be used to select pacing
      lead location in this study.

      The patient will then receive the left ventricular pacing lead in the standard manner.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Nonrandomized survey of different pacing sites in the coronary veins.
primary purpose: Basic Science
masking: None (Open Label)
measure: QRS Frequency at Each Paced Location
time frame: Baseline
description: Time frequency analysis performed at each location
arm group label: Coronary Sinus Branch Pacing
arm group type: Experimental
description: After cannulation, pacing impulses will be delivered via a Biotronik Vision Guidewire to 3 sites (apical, mid ventricular, and basal) within each coronary sinus branch receiving venous blood from the anterior, lateral and posterior regions of the ventricle.
ECG signals will be saved digitally for analysis
intervention type: Device
intervention name: Biotronik Vision Guidewire
description: The apical, mid ventricular and basal sites within the anterior,posterior and lateral coronary sinus branch veins will be paced.
arm group label: Coronary Sinus Branch Pacing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mark J Niebauer, MD, PhD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Cardiomyopathies
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 