<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/NCT03301363</url>
  </required_header>
  <id_info>
    <org_study_id>SCOPE-CRT IRCCSDonato</org_study_id>
    <nct_id>NCT03301363</nct_id>
  </id_info>
  <brief_title>Simultaneous or Sequential Multipoint Pacing</brief_title>
  <acronym>SCOPE-CRT</acronym>
  <official_title>Simultaneous Or Sequential multiPoint Pacing in Cardiac Resynchronization Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Policlinico S. Donato</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Policlinico S. Donato</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study is to compare electrical acute changes between simultaneous and&#xD;
      sequential LV pacing and to assess the paced QRSd over a range of inter- and&#xD;
      intra-ventricular programmable delays setting during MPP pacing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be a prospective, single-arm, non-randomized, non-blinded, acute study&#xD;
      conducted at CRT device implant and prior to subject discharge. Subjects scheduled to be&#xD;
      implanted with a Quadripolar Pacing System who provide informed consent will undergo&#xD;
      &quot;Enrollment&quot; and participate in &quot;SCOPE-CRT&quot; study. Enrollment and device implant can occur in&#xD;
      the same day. Including Enrollment, each subject's participation is expected to be 1-2 days.&#xD;
      The total duration of the study is expected to be 12 months, including Enrollment. Enrollment&#xD;
      will include the Informed Consent process, physical examination, and collection of&#xD;
      demographics, cardiovascular history, medical history, and medications.&#xD;
&#xD;
      During CRT implant, surface ECG and PV loop recordings will be taken over the different&#xD;
      programmable MPP settings. Following data collection, CRT device programming will be left to&#xD;
      the discretion of the physician.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 30, 2017</start_date>
  <completion_date type="Anticipated">November 18, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Acute QRS duration changes during multipoint CRT</measure>
    <time_frame>1 day during CRT</time_frame>
    <description>Quantify acute changes in surface ECG QRS duration between simultaneous and sequential LV pacing during MPP pacing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acute ECG QRS duration changes during multipoint CRT</measure>
    <time_frame>1 day during CRT</time_frame>
    <description>Quantify acute changes in surface ECG QRSd over a range of inter- and intra-ventricular programmable delays setting during multipoint CRT pacing.&#xD;
•</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute changes in hemodynamics between simultaneous and sequential LV pacing during multipoint CRT</measure>
    <time_frame>1 day during CRT</time_frame>
    <description>Quantify acute changes in hemodynamics between simultaneous and sequential LV pacing during multipoint CRT pacing over a range of inter- and intra-ventricular programmable delays settings.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Cardiac Resynchronization Therapy</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CRT</intervention_name>
    <description>Subjects scheduled to be implanted for CRT by a Quadripolar Pacing System</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 50 selected heart failure patients with approved indication for CRT by European&#xD;
        Society of Cardiology/European Heart Rhythm Association guidelines (ESC/EHRA) will be&#xD;
        enrolled for this prospective study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with approved indication for CRT by European Society of Cardiology/European&#xD;
             Heart Rhythm Association guidelines (ESC/EHRA)&#xD;
&#xD;
          -  QRS duration &gt; 130 ms&#xD;
&#xD;
          -  Ability to provide informed consent for study participation&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Myocardial infarction within 40 days before enrolment&#xD;
&#xD;
               -  NYHA Class IV&#xD;
&#xD;
               -  Tachyarrhythmia caused by temporary or reversible irritation, e.g. poisoning,&#xD;
                  electrolyte imbalance, hypoxia, sepsis or acute myocardial infarction&#xD;
&#xD;
               -  Such frequent VT or VF that the therapies would cause an unacceptably rapid&#xD;
                  depletion of the device batteries&#xD;
&#xD;
               -  VT with few or without clinically relevant symptoms&#xD;
&#xD;
               -  VT or VF treatable by surgery&#xD;
&#xD;
               -  Concomitant diseases that would substantially limit a positive prognosis&#xD;
&#xD;
               -  Accelerated intrinsic rhythm&#xD;
&#xD;
               -  Women who are pregnant&#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 Pappone, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS San Donato University Hospital Policlinico San Donato, Milan, Italy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vincenzo Santinelli, MD</last_name>
    <phone>+39 0252774260</phone>
    <email>vincenzo.santinelli@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Carlo Pappone, MD</last_name>
    <phone>+39 0252774260</phone>
    <email>carlo.pappone@af-ablation.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>IRCCS Policlinico S. Donato</name>
      <address>
        <city>San Donato Milanese</city>
        <state>Milano</state>
        <zip>20097</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carlo Pappone, MD, PhD</last_name>
      <phone>00390252774260</phone>
      <email>carlo.pappone@af-ablation.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>November 4, 2021</last_update_submitted>
  <last_update_submitted_qc>November 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Policlinico S. Donato</investigator_affiliation>
    <investigator_full_name>Carlo Pappone</investigator_full_name>
    <investigator_title>Chief of Arrhythmology Department IRCCS SAn Donato Policlinico, University of Milan, Italy</investigator_title>
  </responsible_party>
  <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/NCT03301363
org study id: SCOPE-CRT IRCCSDonato
nct id: NCT03301363
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare electrical acute changes between simultaneous and
      sequential LV pacing and to assess the paced QRSd over a range of inter- and
      intra-ventricular programmable delays setting during MPP pacing.
The study will be a prospective, single-arm, non-randomized, non-blinded, acute study
      conducted at CRT device implant and prior to subject discharge. Subjects scheduled to be
      implanted with a Quadripolar Pacing System who provide informed consent will undergo
      "Enrollment" and participate in "SCOPE-CRT" study. Enrollment and device implant can occur in
      the same day. Including Enrollment, each subject's participation is expected to be 1-2 days.
      The total duration of the study is expected to be 12 months, including Enrollment. Enrollment
      will include the Informed Consent process, physical examination, and collection of
      demographics, cardiovascular history, medical history, and medications.

      During CRT implant, surface ECG and PV loop recordings will be taken over the different
      programmable MPP settings. Following data collection, CRT device programming will be left to
      the discretion of the physician.
observational model: Cohort
time perspective: Prospective
measure: Acute QRS duration changes during multipoint CRT
time frame: 1 day during CRT
description: Quantify acute changes in surface ECG QRS duration between simultaneous and sequential LV pacing during MPP pacing.
measure: Acute ECG QRS duration changes during multipoint CRT
time frame: 1 day during CRT
description: Quantify acute changes in surface ECG QRSd over a range of inter- and intra-ventricular programmable delays setting during multipoint CRT pacing.
•
measure: Acute changes in hemodynamics between simultaneous and sequential LV pacing during multipoint CRT
time frame: 1 day during CRT
description: Quantify acute changes in hemodynamics between simultaneous and sequential LV pacing during multipoint CRT pacing over a range of inter- and intra-ventricular programmable delays settings.
intervention type: Device
intervention name: CRT
description: Subjects scheduled to be implanted for CRT by a Quadripolar Pacing System
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carlo Pappone, MD
role: Principal Investigator
affiliation: IRCCS San Donato University Hospital Policlinico San Donato, Milan, Italy
last name: Vincenzo Santinelli, MD
phone: +39 0252774260
email: vincenzo.santinelli@gmail.com
last name: Carlo Pappone, MD
phone: +39 0252774260
email: carlo.pappone@af-ablation.org
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS Policlinico S. Donato
investigator full name: Carlo Pappone
investigator title: Chief of Arrhythmology Department IRCCS SAn Donato Policlinico, University of Milan, Italy
sharing ipd: No