<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/NCT03258060</url>
  </required_header>
  <id_info>
    <org_study_id>nQRS-CRT</org_study_id>
    <nct_id>NCT03258060</nct_id>
  </id_info>
  <brief_title>CRT In Narrow QRS Heart Failure: Mechanistic Insights From Cardiac MRI And Electroanatomical Mapping</brief_title>
  <official_title>Cardiac Resynchronisation Therapy In Patients With Narrow QRS Morphology And Heart Failure: Mechanistic Insights From Cardiac MRI And Electroanatomical Mapping</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guy's and St Thomas' NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Guy's and St Thomas' NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cardiac Resynchronisation Therapy (CRT) is a specialist pacemaker procedure that aims to&#xD;
      improve the efficiency of the heartbeat. This treatment is used routinely in patients with&#xD;
      heart failure and a delay in electrical conduction across the heart seen on the surface ECG&#xD;
      (heart tracing). Also CRT has been seen to improve some heart failure patients with a normal&#xD;
      electrical conduction (seen on the ECG as a narrow QRS complex). The investigators aim to see&#xD;
      if cardiac MRI can be used to select patients with normal electrical conduction for CRT,&#xD;
      therefore expanding the number of people who would stand to benefit from this treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    release of other trial indicating futility of this study after recruitment of 1 patient&#xD;
  </why_stopped>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">August 18, 2017</completion_date>
  <primary_completion_date type="Actual">August 18, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>LV dP/dT during pacing</measure>
    <time_frame>during temporary pacing study, approximately 2 hours</time_frame>
    <description>To assess LV dP/dT during different pacing modalities by intraventricular pressure wire. A dP/dT change of &gt;10% from baseline is a positive result.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of electrical and mechanical dyssynchrony</measure>
    <time_frame>Data is collected prior to temporary pacing study, the post processing needed in order to correlate this data may take up to 2 months</time_frame>
    <description>To correlate the amount of mechanical dyssynchrony seen prior to pacing with electrical dyssynchrony measures from non-contact mapping and body surface mapping</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Mechanical Dyssynchrony</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Those with cardiac MRI evidence of mechanical dyssynchrony</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Mechanical Dyssynchrony</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Those without mechanical dyssynchrony on cardiac MRI</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Temporary pacing study</intervention_name>
    <arm_group_label>Mechanical Dyssynchrony</arm_group_label>
    <arm_group_label>No Mechanical Dyssynchrony</arm_group_label>
    <other_name>Electrophysiological study</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Body Surface Mapping</intervention_name>
    <arm_group_label>Mechanical Dyssynchrony</arm_group_label>
    <arm_group_label>No Mechanical Dyssynchrony</arm_group_label>
    <other_name>ECG imaging</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Participant is willing and able to give informed consent for participation in the&#xD;
             study.&#xD;
&#xD;
               -  Male or Female, aged 18 years or above.&#xD;
&#xD;
               -  NYHA grade III-IV heart failure&#xD;
&#xD;
               -  LVEF&lt;35%&#xD;
&#xD;
               -  QRS duration &lt;120ms&#xD;
&#xD;
               -  On optimum medical therapy for heart failure&#xD;
&#xD;
               -  Female participants of child bearing potential must be willing to ensure that&#xD;
                  they or their partner use effective contraception during the study and for 3&#xD;
                  months thereafter&#xD;
&#xD;
               -  Able (in the Investigators opinion) and willing to comply with all study&#xD;
                  requirements.&#xD;
&#xD;
               -  Willing to allow his or her General Practitioner and consultant, if appropriate,&#xD;
                  to be notified of participation in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Female participants who is pregnant, lactating or planning pregnancy during the&#xD;
             course of the study.&#xD;
&#xD;
               -  Scheduled elective surgery or other procedures requiring general anaesthesia&#xD;
                  during the study.&#xD;
&#xD;
               -  Participant who is terminally ill or is inappropriate for placebo medication&#xD;
&#xD;
               -  Any other significant disease or disorder which, in the opinion of the&#xD;
                  Investigator, may either put the participants at risk because of participation in&#xD;
                  the study, or may influence the result of the study, or the participant's ability&#xD;
                  to participate in the study.&#xD;
&#xD;
               -  Contraindication to an MRI scan&#xD;
&#xD;
               -  Rate uncontrolled atrial fibrillation precluding a cMR&#xD;
&#xD;
               -  Significant peripheral vascular disease precluding an EP study&#xD;
&#xD;
               -  A contraindication to anticoagulation&#xD;
&#xD;
               -  A prosthetic aortic or tricuspid valve&#xD;
&#xD;
               -  Significant Aortic valve disease&#xD;
&#xD;
               -  Known LV thrombus&#xD;
&#xD;
               -  Insufficient capacity to consent to the study&#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>Aldo Rinaldi, MBBS MD FHRS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guy's and St Thomas' NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Cardiovascular Imaging, King's College London</name>
      <address>
        <city>London</city>
        <zip>SE1 7EF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>March 17, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>August 18, 2017</last_update_submitted>
  <last_update_submitted_qc>August 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Heart Failure</keyword>
  <keyword>Pacing</keyword>
  <keyword>Resynchronization</keyword>
  <keyword>Electrophysiology</keyword>
  <keyword>Imaging</keyword>
  <keyword>Cardiac Resynchronization Therapy</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/NCT03258060
org study id: nQRS-CRT
nct id: NCT03258060
lead sponsor: 
collaborator: 
has dmc: No
Cardiac Resynchronisation Therapy (CRT) is a specialist pacemaker procedure that aims to
      improve the efficiency of the heartbeat. This treatment is used routinely in patients with
      heart failure and a delay in electrical conduction across the heart seen on the surface ECG
      (heart tracing). Also CRT has been seen to improve some heart failure patients with a normal
      electrical conduction (seen on the ECG as a narrow QRS complex). The investigators aim to see
      if cardiac MRI can be used to select patients with normal electrical conduction for CRT,
      therefore expanding the number of people who would stand to benefit from this treatment.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: LV dP/dT during pacing
time frame: during temporary pacing study, approximately 2 hours
description: To assess LV dP/dT during different pacing modalities by intraventricular pressure wire. A dP/dT change of >10% from baseline is a positive result.
measure: Correlation of electrical and mechanical dyssynchrony
time frame: Data is collected prior to temporary pacing study, the post processing needed in order to correlate this data may take up to 2 months
description: To correlate the amount of mechanical dyssynchrony seen prior to pacing with electrical dyssynchrony measures from non-contact mapping and body surface mapping
arm group label: Mechanical Dyssynchrony
arm group type: Active Comparator
description: Those with cardiac MRI evidence of mechanical dyssynchrony
arm group label: No Mechanical Dyssynchrony
arm group type: Active Comparator
description: Those without mechanical dyssynchrony on cardiac MRI
intervention type: Procedure
intervention name: Temporary pacing study
arm group label: Mechanical Dyssynchrony
arm group label: No Mechanical Dyssynchrony
other name: Electrophysiological study
intervention type: Radiation
intervention name: Body Surface Mapping
arm group label: Mechanical Dyssynchrony
arm group label: No Mechanical Dyssynchrony
other name: ECG imaging
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Aldo Rinaldi, MBBS MD FHRS
role: Principal Investigator
affiliation: Guy's and St Thomas' NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Heart Failure