<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/NCT03280862</url>
  </required_header>
  <id_info>
    <org_study_id>1-10-72-330-16</org_study_id>
    <nct_id>NCT03280862</nct_id>
  </id_info>
  <brief_title>DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS</brief_title>
  <official_title>Does Targeted LV Lead Positioning Towards Latest Local Electric Activation at CRT Implantation Reduce Incidence of the Combined Endpoint &quot;Death or Non-planned Hospitalisation for Heart Failure (HF)&quot; in Patients With HF and Prolonged QRS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aalborg University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gentofte University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aarhus University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Heart failure is a leading cause of morbidity and mortality. Cardiac resynchronization&#xD;
      therapy (CRT) is a well-established treatment for patients with symptomatic heart failure in&#xD;
      spite of optimised medical treatment (OMT), reduced left ventricular pump function with left&#xD;
      ventricular ejection fraction (LVEF) ≤ 35% and prolonged activation of the ventricles (bundle&#xD;
      branch block: BBB). CRT is established by implanting an advanced pacemaker system with three&#xD;
      leads in the right atrium, right ventricle, and in the coronary sinus (CS) for pacing the&#xD;
      left ventricle (LV), and often is combined with an implantable defibrillator (ICD) function.&#xD;
      On average, CRT treatment improves longevity, quality of life and functional class, and&#xD;
      reduces heart failure symptoms. Thus, at present, CRT is indicated for heart failure patients&#xD;
      on OMT with BBB or chronic right ventricular (RV) pacing.&#xD;
&#xD;
      It is, however, a significant problem that 30-40% of CRT patients do not benefit measurably -&#xD;
      showing symptomatic improvement or improved cardiac pump function - from this therapy&#xD;
      (socalled non-responders). LV lead placement is one of the major determinants of beneficial&#xD;
      effect from CRT.&#xD;
&#xD;
      Observational studies and three randomised trials with small sample sizes indicate that&#xD;
      targeted placement of the LV lead towards a late activated segment of the LV may be&#xD;
      associated with improved outcome. Based on this literature, some physicians already search&#xD;
      for late activation when positioning the LV lead. However, such a strategy was never tested&#xD;
      in a controlled trial with a sample size sufficient to investigate important clinical&#xD;
      outcomes. Detailed mapping for a late activation may increase operating times and infection&#xD;
      risk, result in use of more electrodes and wires, thereby increasing costs, and increase&#xD;
      radiation exposure for patient and staff. Placement of the LV lead in late activated areas&#xD;
      close to myocardial scar may even result in higher risk of arrhythmia and death.&#xD;
&#xD;
      At present, it is completely unsettled whether targeted positioning of the LV lead to the&#xD;
      latest electrically activated area of LV is superior to contemporary standard CRT with regard&#xD;
      to improving prognosis for patients with heart failure and BBB.&#xD;
&#xD;
      The present study aims to test whether targeting the placement of the LV lead towards the&#xD;
      latest electrically activated segment in the coronary sinus branches improves outcome as&#xD;
      compared with standard LV lead implant in a patient population with heart failure and CRT&#xD;
      indication.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 20, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2026</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2026</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>Double-blind randomised controlled trial. Patients are included and randomised 1:1 into two groups for implantation of either&#xD;
a CRT-D/P device with the LV lead positioned according to the latest electrical activation in the CS (intervention group) or&#xD;
a CRT-D/P device with the LV lead positioned preferentially in a posterolateral, non-apical position (control group)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Patients are unaware of treatment arm. All patients undergo the same pre-implant program and follow-up. Healthcare personel performing follow-up are blinded for treatment arm. Outcome events are evaluated by a committee blinded for treatment arm.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Death or first non-planned hospitalisation for heart failure</measure>
    <time_frame>All patients will be followed until the last included patient has been followed for two years</time_frame>
    <description>Time to death or first non-planned hospitalisation for heart failure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>All patients will be followed until the last included patient has been followed for two years</time_frame>
    <description>Time to death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-planned hospitalisation for heart failure</measure>
    <time_frame>All patients will be followed until the last included patient has been followed for two years</time_frame>
    <description>Time to first non-planned hospitalisation for heart failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sudden death</measure>
    <time_frame>All patients will be followed until the last included patient has been followed for two years</time_frame>
    <description>Time to sudden death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac death</measure>
    <time_frame>All patients will be followed until the last included patient has been followed for two years</time_frame>
    <description>Time to cardiac death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical response</measure>
    <time_frame>Follow-up at 3, 6, 12, 24 and 48 months</time_frame>
    <description>Increase in New York Heart Association (NYHA) class (≥1 class from baseline) or improved walking distance by six-minute walk test (6MWT) (≥10% from baseline)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QoL)</measure>
    <time_frame>Follow-up at 6, 12, 24 and 48 months</time_frame>
    <description>Changes in score from baseline to follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcomes (PROs)</measure>
    <time_frame>Follow-up at 6, 12, 24 and 48 months</time_frame>
    <description>Changes in score from baseline to follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Echocardiographic measures of LV function</measure>
    <time_frame>Follow-up at 6, 12, 24 and 48 months</time_frame>
    <description>Changes from baseline to follow-up in left ventricular ejection fraction (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first appropriate ICD Therapy</measure>
    <time_frame>All patients will be followed until the last included patient has been followed for two years</time_frame>
    <description>Time to first appropriate ICD therapy (antitachycardia pacing (ATP) or shock therapy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first inappropriate ICD Therapy</measure>
    <time_frame>All patients will be followed until the last included patient has been followed for two years</time_frame>
    <description>Time to first inappropriate ICD therapy (antitachycardia pacing (ATP) or shock therapy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numbers of appropriate ICD Therapies</measure>
    <time_frame>All patients will be followed until the last included patient has been followed for two years</time_frame>
    <description>Numbers of appropriate ICD therapies (antitachycardia pacing (ATP) or shock therapy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numbers of inappropriate ICD Therapies</measure>
    <time_frame>All patients will be followed until the last included patient has been followed for two years</time_frame>
    <description>Numbers of inappropriate ICD therapies (antitachycardia pacing (ATP) or shock therapy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventricular tachycardia (VT)/ventricular fibrillation (VF)</measure>
    <time_frame>All patients will be followed until the last included patient has been followed for two years</time_frame>
    <description>Time to first episode of VT/VF</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Persistent atrial fibrillation</measure>
    <time_frame>All patients will be followed until the last included patient has been followed for two years</time_frame>
    <description>Recorded by the implanted device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any atrial fibrillation</measure>
    <time_frame>All patients will be followed until the last included patient has been followed for two years</time_frame>
    <description>&gt;30 seconds recorded by the implanted device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implantation time</measure>
    <time_frame>0-6 hours, assessed at completion of implantation procedure</time_frame>
    <description>Procedure time at implantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluoroscopy time</measure>
    <time_frame>0-120 minutes, assessed at completion of implantation procedure</time_frame>
    <description>Fluoroscopy time at implantation in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluoroscopy dose</measure>
    <time_frame>Assessed &lt;24 hours after implantation initiation</time_frame>
    <description>Fluoroscopy dose at implantation in mGy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Equipment used at implantation</measure>
    <time_frame>Assessed &lt;24 hours after implantation initiation</time_frame>
    <description>Number of LV leads (0-5) used at implantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device-related outcomes</measure>
    <time_frame>All patients will be followed until the last included patient has been followed for two years</time_frame>
    <description>Periprocedural: lead re-operation, pneumothorax, hemothorax, pericardial bleeding/tamponade and later (30 days post implantation): LV lead re-operation, device replacement due to battery depletion, and infection requiring extraction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Battery replacements</measure>
    <time_frame>All patients will be followed until the last included patient has been followed for two years</time_frame>
    <description>Number of device replacements during the study period due to battery depletion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Battery longevity estimate</measure>
    <time_frame>All patients will be followed until the last included patient has been followed for two years</time_frame>
    <description>Measured by actual device battery longevity + estimated remaining device battery longevity as reported by the device at last study follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QRS complex width</measure>
    <time_frame>All patients will be followed until the last included patient has been followed for two years</time_frame>
    <description>Changes in the ECG parameter QRS complex width during follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QRS complex morphology</measure>
    <time_frame>All patients will be followed until the last included patient has been followed for two years</time_frame>
    <description>Changes in the ECG parameter QRS complex morphology during follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Predictive value of P-wave</measure>
    <time_frame>All patients will be followed until the last included patient has been followed for two years</time_frame>
    <description>Predictive value of the baseline ECG parameter P-wave on clinical outcome measures in the entire cohort and between the two treatment groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Predictive value of QRS complex width</measure>
    <time_frame>All patients will be followed until the last included patient has been followed for two years</time_frame>
    <description>Predictive value of the baseline ECG parameter QRS complex width on clinical outcome measures in the entire cohort and between the two treatment groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Predictive value of QRS complex morphology</measure>
    <time_frame>All patients will be followed until the last included patient has been followed for two years</time_frame>
    <description>Predictive value of the baseline ECG parameter QRS complex morphology on clinical outcome measures in the entire cohort and between the two treatment groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in cardiac chamber dimensions</measure>
    <time_frame>All patients will be followed until the last included patient has been followed for two years</time_frame>
    <description>Volumes of cardiac chambers (left ventricle, left atrium, right ventricle, right atrium) measured by echocardiography and cardiac CT during follow-up in the entire cohort and between the two treatment groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in left ventricular ejection fraction LVEF</measure>
    <time_frame>All patients will be followed until the last included patient has been followed for two years</time_frame>
    <description>Changes in cardiac chamber function measured by echocardiography and cardiac CT during follow-up in the entire cohort and between the two treatment groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in right ventricular ejection fraction RVEF</measure>
    <time_frame>All patients will be followed until the last included patient has been followed for two years</time_frame>
    <description>Changes in cardiac chamber function measured by echocardiography and cardiac CT during follow-up in the entire cohort and between the two treatment groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Heart Failure</condition>
  <condition>Branch Block, Bundle</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Implantation of a Cardiac Resynchronisation Therapy (CRT) pacing device with or without Implanted Cardioverter Defibrillator with the LV lead positioned preferentially in a posterolateral, non-apical position</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implantation of a Cardiac Resynchronisation Therapy (CRT) pacing device with or without Implanted Cardioverter Defibrillator with the LV lead positioned according to the latest electrical activation in the CS</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Implantation of a Cardiac Resynchronisation Therapy (CRT) pacing device with or without Implanted Cardioverter Defibrillator</intervention_name>
    <description>Implantation of CRT-P/-D device</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Heart Failure, NYHA II, III, outpatient IV&#xD;
&#xD;
          -  LVEF ≤35% measured by echocardiography&#xD;
&#xD;
          -  Optimal medical treatment for heart failure&#xD;
&#xD;
          -  Bundle Branch Block&#xD;
&#xD;
          -  Indication for primary CRT-D or CRT-P implantation or upgrade from RV pacing&#xD;
             (pacemaker or ICD) to CRT-D or CRT-P&#xD;
&#xD;
          -  Ischemic heart disease (IHD) or non-IHD&#xD;
&#xD;
          -  Sinus rhythm or atrial fibrillation&#xD;
&#xD;
          -  Life expectancy &gt;2 years&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  NYHA class I&#xD;
&#xD;
          -  Acute mycardial infarction (AMI) within the latest 3 months&#xD;
&#xD;
          -  Coronary artery bypass graft (CABG) within the latest 3 months&#xD;
&#xD;
          -  Life expectancy &lt;2 years&#xD;
&#xD;
          -  Participation in another clinical trial of experimental treatment&#xD;
&#xD;
          -  Contraindication for establishing implantable device treatment&#xD;
&#xD;
          -  Previously implanted CRT system&#xD;
&#xD;
          -  Does not wish to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jens C Nielsen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aarhus University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jens C Nielsen</last_name>
    <phone>+45 40188448</phone>
    <email>jenniels@rm.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Henriette Holmberg</last_name>
    <phone>+45 7845 2115</phone>
    <email>henrholm@rm.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Aalborg University Hospital</name>
      <address>
        <city>Aalborg</city>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Sam Riahi, DMSc</last_name>
      <phone>+45 40638681</phone>
      <email>sar@rn.dk</email>
    </contact>
    <investigator>
      <last_name>Sam Riahi, DMSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jens C Nielsen, DMSc</last_name>
      <phone>+45 40135295</phone>
      <email>jenniels@rm.dk</email>
    </contact>
    <investigator>
      <last_name>Jens C Nielsen, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jesper H Svendsen, DMSc</last_name>
      <phone>+45 35458061</phone>
      <email>Jesper.Hastrup.Svendsen@regionh.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Gentofte University Hospital</name>
      <address>
        <city>Gentofte</city>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jens Haarbo, DMSc</last_name>
      <phone>+45 39773335</phone>
      <email>Jens.Haarbo@regionh.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jens B Johansen, PhD</last_name>
      <phone>+45 6412722</phone>
      <email>brock@dadlnet.dk</email>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>January 31, 2023</last_update_submitted>
  <last_update_submitted_qc>January 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aarhus University Hospital</investigator_affiliation>
    <investigator_full_name>Jens Cosedis Nielsen</investigator_full_name>
    <investigator_title>Professor, DMSc, PhD, FESC, FEHRA</investigator_title>
  </responsible_party>
  <keyword>Heart Failure</keyword>
  <keyword>Branch Block</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>
    <mesh_term>Bundle-Branch Block</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/NCT03280862
org study id: 1-10-72-330-16
nct id: NCT03280862
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Heart failure is a leading cause of morbidity and mortality. Cardiac resynchronization
      therapy (CRT) is a well-established treatment for patients with symptomatic heart failure in
      spite of optimised medical treatment (OMT), reduced left ventricular pump function with left
      ventricular ejection fraction (LVEF) ≤ 35% and prolonged activation of the ventricles (bundle
      branch block: BBB). CRT is established by implanting an advanced pacemaker system with three
      leads in the right atrium, right ventricle, and in the coronary sinus (CS) for pacing the
      left ventricle (LV), and often is combined with an implantable defibrillator (ICD) function.
      On average, CRT treatment improves longevity, quality of life and functional class, and
      reduces heart failure symptoms. Thus, at present, CRT is indicated for heart failure patients
      on OMT with BBB or chronic right ventricular (RV) pacing.

      It is, however, a significant problem that 30-40% of CRT patients do not benefit measurably -
      showing symptomatic improvement or improved cardiac pump function - from this therapy
      (socalled non-responders). LV lead placement is one of the major determinants of beneficial
      effect from CRT.

      Observational studies and three randomised trials with small sample sizes indicate that
      targeted placement of the LV lead towards a late activated segment of the LV may be
      associated with improved outcome. Based on this literature, some physicians already search
      for late activation when positioning the LV lead. However, such a strategy was never tested
      in a controlled trial with a sample size sufficient to investigate important clinical
      outcomes. Detailed mapping for a late activation may increase operating times and infection
      risk, result in use of more electrodes and wires, thereby increasing costs, and increase
      radiation exposure for patient and staff. Placement of the LV lead in late activated areas
      close to myocardial scar may even result in higher risk of arrhythmia and death.

      At present, it is completely unsettled whether targeted positioning of the LV lead to the
      latest electrically activated area of LV is superior to contemporary standard CRT with regard
      to improving prognosis for patients with heart failure and BBB.

      The present study aims to test whether targeting the placement of the LV lead towards the
      latest electrically activated segment in the coronary sinus branches improves outcome as
      compared with standard LV lead implant in a patient population with heart failure and CRT
      indication.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Double-blind randomised controlled trial. Patients are included and randomised 1:1 into two groups for implantation of either
a CRT-D/P device with the LV lead positioned according to the latest electrical activation in the CS (intervention group) or
a CRT-D/P device with the LV lead positioned preferentially in a posterolateral, non-apical position (control group)
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Patients are unaware of treatment arm. All patients undergo the same pre-implant program and follow-up. Healthcare personel performing follow-up are blinded for treatment arm. Outcome events are evaluated by a committee blinded for treatment arm.
measure: Death or first non-planned hospitalisation for heart failure
time frame: All patients will be followed until the last included patient has been followed for two years
description: Time to death or first non-planned hospitalisation for heart failure
measure: Death
time frame: All patients will be followed until the last included patient has been followed for two years
description: Time to death
measure: Non-planned hospitalisation for heart failure
time frame: All patients will be followed until the last included patient has been followed for two years
description: Time to first non-planned hospitalisation for heart failure
measure: Sudden death
time frame: All patients will be followed until the last included patient has been followed for two years
description: Time to sudden death
measure: Cardiac death
time frame: All patients will be followed until the last included patient has been followed for two years
description: Time to cardiac death
measure: Clinical response
time frame: Follow-up at 3, 6, 12, 24 and 48 months
description: Increase in New York Heart Association (NYHA) class (≥1 class from baseline) or improved walking distance by six-minute walk test (6MWT) (≥10% from baseline)
measure: Quality of Life (QoL)
time frame: Follow-up at 6, 12, 24 and 48 months
description: Changes in score from baseline to follow-up
measure: Patient Reported Outcomes (PROs)
time frame: Follow-up at 6, 12, 24 and 48 months
description: Changes in score from baseline to follow-up
measure: Echocardiographic measures of LV function
time frame: Follow-up at 6, 12, 24 and 48 months
description: Changes from baseline to follow-up in left ventricular ejection fraction (%)
measure: Time to first appropriate ICD Therapy
time frame: All patients will be followed until the last included patient has been followed for two years
description: Time to first appropriate ICD therapy (antitachycardia pacing (ATP) or shock therapy)
measure: Time to first inappropriate ICD Therapy
time frame: All patients will be followed until the last included patient has been followed for two years
description: Time to first inappropriate ICD therapy (antitachycardia pacing (ATP) or shock therapy)
measure: Numbers of appropriate ICD Therapies
time frame: All patients will be followed until the last included patient has been followed for two years
description: Numbers of appropriate ICD therapies (antitachycardia pacing (ATP) or shock therapy)
measure: Numbers of inappropriate ICD Therapies
time frame: All patients will be followed until the last included patient has been followed for two years
description: Numbers of inappropriate ICD therapies (antitachycardia pacing (ATP) or shock therapy)
measure: Ventricular tachycardia (VT)/ventricular fibrillation (VF)
time frame: All patients will be followed until the last included patient has been followed for two years
description: Time to first episode of VT/VF
measure: Persistent atrial fibrillation
time frame: All patients will be followed until the last included patient has been followed for two years
description: Recorded by the implanted device
measure: Any atrial fibrillation
time frame: All patients will be followed until the last included patient has been followed for two years
description: >30 seconds recorded by the implanted device
measure: Implantation time
time frame: 0-6 hours, assessed at completion of implantation procedure
description: Procedure time at implantation
measure: Fluoroscopy time
time frame: 0-120 minutes, assessed at completion of implantation procedure
description: Fluoroscopy time at implantation in minutes
measure: Fluoroscopy dose
time frame: Assessed <24 hours after implantation initiation
description: Fluoroscopy dose at implantation in mGy
measure: Equipment used at implantation
time frame: Assessed <24 hours after implantation initiation
description: Number of LV leads (0-5) used at implantation
measure: Device-related outcomes
time frame: All patients will be followed until the last included patient has been followed for two years
description: Periprocedural: lead re-operation, pneumothorax, hemothorax, pericardial bleeding/tamponade and later (30 days post implantation): LV lead re-operation, device replacement due to battery depletion, and infection requiring extraction
measure: Battery replacements
time frame: All patients will be followed until the last included patient has been followed for two years
description: Number of device replacements during the study period due to battery depletion
measure: Battery longevity estimate
time frame: All patients will be followed until the last included patient has been followed for two years
description: Measured by actual device battery longevity + estimated remaining device battery longevity as reported by the device at last study follow-up
measure: QRS complex width
time frame: All patients will be followed until the last included patient has been followed for two years
description: Changes in the ECG parameter QRS complex width during follow-up
measure: QRS complex morphology
time frame: All patients will be followed until the last included patient has been followed for two years
description: Changes in the ECG parameter QRS complex morphology during follow-up
measure: Predictive value of P-wave
time frame: All patients will be followed until the last included patient has been followed for two years
description: Predictive value of the baseline ECG parameter P-wave on clinical outcome measures in the entire cohort and between the two treatment groups
measure: Predictive value of QRS complex width
time frame: All patients will be followed until the last included patient has been followed for two years
description: Predictive value of the baseline ECG parameter QRS complex width on clinical outcome measures in the entire cohort and between the two treatment groups
measure: Predictive value of QRS complex morphology
time frame: All patients will be followed until the last included patient has been followed for two years
description: Predictive value of the baseline ECG parameter QRS complex morphology on clinical outcome measures in the entire cohort and between the two treatment groups
measure: Changes in cardiac chamber dimensions
time frame: All patients will be followed until the last included patient has been followed for two years
description: Volumes of cardiac chambers (left ventricle, left atrium, right ventricle, right atrium) measured by echocardiography and cardiac CT during follow-up in the entire cohort and between the two treatment groups
measure: Changes in left ventricular ejection fraction LVEF
time frame: All patients will be followed until the last included patient has been followed for two years
description: Changes in cardiac chamber function measured by echocardiography and cardiac CT during follow-up in the entire cohort and between the two treatment groups
measure: Changes in right ventricular ejection fraction RVEF
time frame: All patients will be followed until the last included patient has been followed for two years
description: Changes in cardiac chamber function measured by echocardiography and cardiac CT during follow-up in the entire cohort and between the two treatment groups
arm group label: Control
arm group type: Active Comparator
description: Implantation of a Cardiac Resynchronisation Therapy (CRT) pacing device with or without Implanted Cardioverter Defibrillator with the LV lead positioned preferentially in a posterolateral, non-apical position
arm group label: Intervention
arm group type: Experimental
description: Implantation of a Cardiac Resynchronisation Therapy (CRT) pacing device with or without Implanted Cardioverter Defibrillator with the LV lead positioned according to the latest electrical activation in the CS
intervention type: Device
intervention name: Implantation of a Cardiac Resynchronisation Therapy (CRT) pacing device with or without Implanted Cardioverter Defibrillator
description: Implantation of CRT-P/-D device
arm group label: Control
arm group label: Intervention
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Jens C Nielsen
role: Principal Investigator
affiliation: Aarhus University Hospital
last name: Jens C Nielsen
phone: +45 40188448
email: jenniels@rm.dk
last name: Henriette Holmberg
phone: +45 7845 2115
email: henrholm@rm.dk
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aarhus University Hospital
investigator full name: Jens Cosedis Nielsen
investigator title: Professor, DMSc, PhD, FESC, FEHRA
mesh term: Heart Failure
mesh term: Bundle-Branch Block
sharing ipd: No