<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/NCT02235766</url>
  </required_header>
  <id_info>
    <org_study_id>Kell-1</org_study_id>
    <nct_id>NCT02235766</nct_id>
  </id_info>
  <brief_title>Corelab Remotely Echocardiographic Imaging Acquisition in Cardiac Resynchronization Therapy Candidates</brief_title>
  <acronym>CORELAB-CRT</acronym>
  <official_title>Corelab Remotely Echocardiographic Imaging Acquisition in Cardiac Resynchronization Therapy Candidates</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kell s.r.l.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kell s.r.l.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose of the observational study is to assess the capability of a satellite&#xD;
      tele-echocardiography (STE) system to acquire and transmit echocardiographic images and clips&#xD;
      to an echocardiographic core laboratory (ECL) in a real time mode without loss of quality.&#xD;
      Additionally the prognostic efficacy of specific echo parameters in the cardiac&#xD;
      resynchronization therapy response will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CORELAB-CRT is a prospective multi center Italian observational study. All echo images and&#xD;
      clips will be transmitted by using an integrated satellite transmission system. All echo&#xD;
      assessments performed in accordance to the centers clinical practice will be also used to&#xD;
      investigate the prognostic efficacy of echo parameters in term of response to the cardiac&#xD;
      resynchronization therapy (CRT). All commercially available multi-chamber CRT-D devices from&#xD;
      any manufacturers are allowed in this observational study.&#xD;
&#xD;
      Any compatible market released right atrial, right ventricular and left ventricular lead from&#xD;
      any manufacturer is allowed.&#xD;
&#xD;
      The echocardiography device models used to perform echo imaging for all patients&#xD;
      participating in this analysis are GE Vivid 7, GE Vivid 9 and GE Vivid I, according to the&#xD;
      model used in the clinical practice of the hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2015</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>ECM assessment</measure>
    <time_frame>6 months</time_frame>
    <description>Agreement in the echocardiographic measurement capability (EMC) between transmitted and echocardiographic device image on the set of high quality images transmitted by STE. Each echo image will be classified as high quality image if the Mean Opinion Score (MOS) will be greater than 3 points. For each high quality echo image (MOS greater or equal 3) the EMC will be assessed to both transmitted and device echocardiographic image.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prognostic efficacy of specific echo parameters</measure>
    <time_frame>6 months</time_frame>
    <description>Echocardiographic response defined as LVESV reduction ≥10% at 6 months after CRT-D implantation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical composite score CCS</measure>
    <time_frame>6 months</time_frame>
    <description>CCS describing patients regardless of vital status at 6 months and includes both objective and subjective measures of clinical status.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>CRT candidates patients</arm_group_label>
    <description>In accordance with the current ESC/ACCF/AHA indications for CRT in sinus rhythm, all patients in NYHA class II, III and IV with QRS complex greater than 120 msec and ejection fraction equal or less than 35% will be considered eligible to participate in this observational study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Echocardiographic assessment</intervention_name>
    <arm_group_label>CRT candidates patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        In accordance with the current ESC/ACCF/AHA indications for CRT in sinus rhythm, all&#xD;
        patients in NYHA class II, III and IV with QRS complex greater than 120 msec and ejection&#xD;
        fraction equal or less than 35% will be considered eligible to participate in this&#xD;
        observational study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. NYHA class II, III and ambulatory IV with:&#xD;
&#xD;
               -  QRS complex duration ≥120msec;&#xD;
&#xD;
               -  Ejection fraction ≤35%.&#xD;
&#xD;
          2. Optimized medical treatment;&#xD;
&#xD;
          3. Patient in sinus rhythm;&#xD;
&#xD;
          4. Patient is willing and able to sign an informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unstable angina, or acute myocardial infarction, coronary-aortic bypass graft or&#xD;
             percutaneous transluminal coronary angioplasty within the past 3 months;&#xD;
&#xD;
          2. Cerebral vascular attacks or transient ischemic attack within the last month;&#xD;
&#xD;
          3. Chronic atrial arrhythmias, paroxysmal atrial fibrillation events;&#xD;
&#xD;
          4. Patients already implanted with an ICD or a CRT device;&#xD;
&#xD;
          5. Pacemaker dependency or ventricular pacing percentage ≥10%;&#xD;
&#xD;
          6. Valvular disease with an indication for surgical correction ≤12 months survival&#xD;
             expectancy;&#xD;
&#xD;
          7. Mechanical right ventricular valve;&#xD;
&#xD;
          8. Patient is enrolled in or intends to participate in another clinical trial that may&#xD;
             have an impact on the study endpoints;&#xD;
&#xD;
          9. Pregnancy or breastfeeding;&#xD;
&#xD;
         10. Previous heart transplant;&#xD;
&#xD;
         11. Refusal of study informed consent;&#xD;
&#xD;
         12. Expected lack of compliance during follow-up;&#xD;
&#xD;
         13. Patient is less than 18 years of age;&#xD;
&#xD;
         14. Patient's life expectancy is less than 6 months in the opinion of physician.&#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>Carlo Peraldo Neja</last_name>
    <role>Principal Investigator</role>
    <affiliation>CORELAB Responsible</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cesare Aragno</last_name>
    <role>Study Director</role>
    <affiliation>Kell s.r.l.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cesare Aragno</last_name>
    <phone>+39 06 36004916</phone>
    <email>caragno@kell.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>S.Camillo de Lellis Hospital</name>
      <address>
        <city>Rieti</city>
        <zip>02100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Serafino Orazi, MD</last_name>
    </contact>
    <investigator>
      <last_name>Serafino Orazi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Giuseppe Stifano, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>S.Eugenio Hospital</name>
      <address>
        <city>Rome</city>
        <zip>00144</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Filippo Lamberti, MD</last_name>
    </contact>
    <investigator>
      <last_name>Filippo Lamberti, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Francesca Di Clemente, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital Campus Bio-Medico</name>
      <address>
        <city>Rome</city>
        <zip>00144</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Simona Mega, MD</last_name>
    </contact>
    <investigator>
      <last_name>Simona Mega, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Danilo Ricciardi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fatebenefratelli Hospital</name>
      <address>
        <city>Rome</city>
        <zip>00186</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gaetano Luca Panetta, MD</last_name>
    </contact>
    <investigator>
      <last_name>Gaetano Luca Panetta, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Francesca Toscano, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>March 3, 2016</last_update_submitted>
  <last_update_submitted_qc>March 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiac Resynchronization Therapy</keyword>
  <keyword>Satellite Tele-Echocardiography</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/NCT02235766
org study id: Kell-1
nct id: NCT02235766
lead sponsor: 
has dmc: No
Purpose of the observational study is to assess the capability of a satellite
      tele-echocardiography (STE) system to acquire and transmit echocardiographic images and clips
      to an echocardiographic core laboratory (ECL) in a real time mode without loss of quality.
      Additionally the prognostic efficacy of specific echo parameters in the cardiac
      resynchronization therapy response will be evaluated.
CORELAB-CRT is a prospective multi center Italian observational study. All echo images and
      clips will be transmitted by using an integrated satellite transmission system. All echo
      assessments performed in accordance to the centers clinical practice will be also used to
      investigate the prognostic efficacy of echo parameters in term of response to the cardiac
      resynchronization therapy (CRT). All commercially available multi-chamber CRT-D devices from
      any manufacturers are allowed in this observational study.

      Any compatible market released right atrial, right ventricular and left ventricular lead from
      any manufacturer is allowed.

      The echocardiography device models used to perform echo imaging for all patients
      participating in this analysis are GE Vivid 7, GE Vivid 9 and GE Vivid I, according to the
      model used in the clinical practice of the hospital.
observational model: Case-Only
time perspective: Prospective
measure: ECM assessment
time frame: 6 months
description: Agreement in the echocardiographic measurement capability (EMC) between transmitted and echocardiographic device image on the set of high quality images transmitted by STE. Each echo image will be classified as high quality image if the Mean Opinion Score (MOS) will be greater than 3 points. For each high quality echo image (MOS greater or equal 3) the EMC will be assessed to both transmitted and device echocardiographic image.
measure: Prognostic efficacy of specific echo parameters
time frame: 6 months
description: Echocardiographic response defined as LVESV reduction ≥10% at 6 months after CRT-D implantation.
measure: Clinical composite score CCS
time frame: 6 months
description: CCS describing patients regardless of vital status at 6 months and includes both objective and subjective measures of clinical status.
arm group label: CRT candidates patients
description: In accordance with the current ESC/ACCF/AHA indications for CRT in sinus rhythm, all patients in NYHA class II, III and IV with QRS complex greater than 120 msec and ejection fraction equal or less than 35% will be considered eligible to participate in this observational study.
intervention type: Other
intervention name: Echocardiographic assessment
arm group label: CRT candidates patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carlo Peraldo Neja
role: Principal Investigator
affiliation: CORELAB Responsible
last name: Cesare Aragno
role: Study Director
affiliation: Kell s.r.l.
last name: Cesare Aragno
phone: +39 06 36004916
email: caragno@kell.it
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Italy
responsible party type: Sponsor
mesh term: Heart Failure