<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/NCT01694394</url>
  </required_header>
  <id_info>
    <org_study_id>ASSERT-II</org_study_id>
    <nct_id>NCT01694394</nct_id>
  </id_info>
  <brief_title>Prevalence of Sub-Clinical Atrial Fibrillation Using an Implantable Cardiac Monitor</brief_title>
  <acronym>ASSERT-II</acronym>
  <official_title>Prevalence of Sub-Clinical Atrial Fibrillation Using an Implantable Cardiac Monitor in Patient With Cardiovascular Risk Factors (ASSERT-II)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Population Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Population Health Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to determine the rate of detection of sub-clinical&#xD;
      atrial fibrillation (≥ 5 minutes)within an average of 12 months following implant of the St.&#xD;
      Jude Medical Confirm(R) Implantable Cardiac Monitor in patients with known cardiovascular&#xD;
      risk factors and left atrial enlargement, but without prior AF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Title of Study Prevalence of Sub-Clinical Atrial Fibrillation Using an Implantable Cardiac&#xD;
      Monitor in Patients with Cardiovascular Risk Factors (ASSERT-II) Short Title ASSERT-II Study&#xD;
      Sponsor Population Health Research Institute (Grant in Aid from St. Jude Medical, Inc.)&#xD;
      Principal Investigators Dr. J. Healey, Dr. S. Connolly, Dr. M. Alings Central Coordinating&#xD;
      Centre Population Health Research Institute Recruitment and Participating Clinical Sites 250&#xD;
      patients from approximately 30 Sites Phase/Regulatory Status Phase IV - Cohort Study&#xD;
      Hypothesis Among elderly patients with cardiovascular risk factors and a left atrial diameter&#xD;
      ≥ 4.4 cm, but without prior clinical AF, an implanted continuous ECG monitor (St. Jude&#xD;
      Medical Confirm® Implantable Cardiac Monitor) will detect subclinical AF (≥ 5 minutes in&#xD;
      duration) in 12% or more of patients during an average follow-up of 12 months.&#xD;
&#xD;
      Study Objectives&#xD;
&#xD;
      Primary Objectives:&#xD;
&#xD;
      1. To determine the rate of detection of sub-clinical atrial AF (≥ 5 minutes) within an&#xD;
      average of 12 months following implant of the St. Jude Medical Confirm® Implantable Cardiac&#xD;
      Monitor in patients with known cardiovascular risk factors and left atrial enlargement, but&#xD;
      without prior AF.&#xD;
&#xD;
      Secondary Objectives&#xD;
&#xD;
        1. To determine if the incidence of sub-clinical AF is higher among patients whose left&#xD;
           atrial volume is above the median value observed in this study.&#xD;
&#xD;
        2. To determine the relationship between left atrial volume (continuous variable) and the&#xD;
           risk of sub-clinical AF.&#xD;
&#xD;
        3. To evaluate other potential predictors of sub-acute AF in this population including:&#xD;
           baseline troponin-T, baseline NT-pro-BNP as well as clinical and other echocardiographic&#xD;
           parameters.&#xD;
&#xD;
        4. To develop a preliminary economic analysis to evaluate the potential cost-effectiveness&#xD;
           of screening this patient population with an Implantable Cardiac Monitor as a means of&#xD;
           preventing stroke.&#xD;
&#xD;
      Study Design Cohort study to determine the prevalence of sub-clinical AF in an elderly&#xD;
      population with common cardiovascular risk factors, such as hypertension and diabetes.&#xD;
      Patients with echocardiographic evidence of atrial enlargement will be enrolled and have the&#xD;
      St. Jude Medical Confirm® Implantable Cardiac Monitor (Confirm® ICM) subcutaneously&#xD;
      implanted. To reduce costs, in most cases the implant will be done in conjunction with other&#xD;
      planned surgery or heart catheterization.&#xD;
&#xD;
      PHRI: CONFIDENTIAL Final Version 2.0:2012-06-18 Page 4 of 24 Participants/Study Duration&#xD;
      Total of 250 participants will be enrolled over 16 months. The last patient enrolled will&#xD;
      have 9 months of follow-up, for a total study duration of approximately 25 months. Clinic&#xD;
      visits will occur at enrolment and months 3, 6 and 9. A final visit will take place at 18&#xD;
      months of follow-up, or after the last patient enrolled has been followed for 9 months&#xD;
      (whichever comes first).&#xD;
&#xD;
      Study Population Patients with known cardiovascular risk factors and left atrial enlargement,&#xD;
      with no prior documented AF.&#xD;
&#xD;
      Intervention St. Jude Medical Confirm® Implantable Cardiac Monitor (Confirm® ICM) Enrollment&#xD;
      and Follow-up Eligible and consenting patients will be enrolled and have the Confirm® ICM&#xD;
      implanted. The implant may take place in conjunction with pre-planned non-cardiac surgery,&#xD;
      heart catheterization, or as a stand-alone procedure. Follow-up visits will occur at month 3,&#xD;
      6 and 9. A final visit will take place at 18 months of follow-up, or after the last patient&#xD;
      enrolled has been followed for 9 months (whichever comes first).&#xD;
&#xD;
      Assessment of Outcome Events An independent central adjudication committee comprised of&#xD;
      arrhythmia experts will evaluate device-detected AF episodes.&#xD;
&#xD;
      Statistical Methodology Determine the incidence of sub-clinical atrial AF (≥ 5 minutes) using&#xD;
      the Confirm® ICM.&#xD;
&#xD;
      Date of Protocol June 18, 2012&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>First atrial fibrillation episode at least 5 minutes in duration</measure>
    <time_frame>over maximum follow-up of 18 months</time_frame>
    <description>incidence of atrial fibrillation detected by continuous monitoring by an implantable cardiac monitor</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">256</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
    <description>Single arm cohort will receive a St. Jude Medical Implantable Cardiac Monitor (Confirm ICM model 2102) for continuous monitoring over the study follow-up period to determine incidence of sub-clinical atrial fibrillation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Implantable Cardiac Monitor (Confirm ICM model 2102)</intervention_name>
    <description>Patients who meet the study criteria will be implanted with a St. Jude Medical Confirm Implantable Cardiac Monitor (Confirm ICM) model 2102 or other St. Jude Medical ICM with the same capabilities.</description>
    <arm_group_label>Cohort</arm_group_label>
    <other_name>St. Jude Medical Confirm ICM model 2102</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood will be collected for NT-ProBNP and hs-Troponin-T&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients at increased risk of atrial fibrillation and cardiovascular events but without&#xD;
        prior history of atrial fibrillation or implanted pacemaker or defibrillator&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        Patients will be eligible for inclusion if they meet both of the following:&#xD;
&#xD;
          1. Age ≥ 65, plus:&#xD;
&#xD;
               -  CHA2DS2-VASc score ≥ 2 Or&#xD;
&#xD;
               -  Obstructive sleep apnea (documented by polysomnography, ambulatory oximetry,&#xD;
                  positive Berlin Questionnaire or requiring the use of CPAP/BiPAP) Or&#xD;
&#xD;
               -  BMI &gt; 30&#xD;
&#xD;
          2. Echocardiographic or biochemical evidence of increased risk of AF:&#xD;
&#xD;
               -  Left atrial enlargement on a clinical echocardiography at any time prior to&#xD;
                  enrollment ( defined as LA volume ≥ 58 ml or LA diameter of ≥ 4.4 cm) Or&#xD;
&#xD;
               -  Serum NT-ProBNP ≥ 290 pg/mL Exclusion Criteria&#xD;
&#xD;
        1. Previously documented history of atrial fibrillation or atrial flutter 2. Current&#xD;
        chronic treatment with oral anticoagulation (i.e. those on peri-operative prophylaxis would&#xD;
        be eligible) 3. Patient with implanted pacemaker or defibrillator with an atrial lead 4.&#xD;
        Definitive plan for cardiac surgery in the next 6 months (patients who are having coronary&#xD;
        angiography with a possibility of cardiac surgery are still eligible)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeff Healey, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Population Health Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stuart Connolly, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Population Health Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marco Alings, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Working group Cardiovascular research Netherlands</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 2T9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Boniface Hospital</name>
      <address>
        <city>Winnepeg</city>
        <state>Manitoba</state>
        <zip>R2H 2A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth-II Heather Sciences Center</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 3A7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton Health Sciences - Electrophysiology Clinic</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8L 2X2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton Health Sciences - Interventional Cardiology</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8L 2X2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton Health Sciences - Perioperative Ischemia Research Group</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8L 2X2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Health Sciences Center University Hospital</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southlake Regional HealthCare</name>
      <address>
        <city>Newmarket</city>
        <state>Ontario</state>
        <zip>L3Y 2P9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Ottawa Heart Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>613-761-5208</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Sciences North</name>
      <address>
        <city>Sudbury</city>
        <state>Ontario</state>
        <zip>P3E 5J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H9S 1H4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Hopital Laval)</name>
      <address>
        <city>Sainte-Foy</city>
        <state>Quebec</state>
        <zip>G1V 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academisch Medisch Centrum (AMC) Amsterdam</name>
      <address>
        <city>Amsterdam</city>
        <zip>1100 DD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amphia Hospital</name>
      <address>
        <city>Breda</city>
        <zip>4818 CK</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nij Smellinge</name>
      <address>
        <city>Drachten</city>
        <zip>9202 DA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groene Hart Ziekenhuis Gouda</name>
      <address>
        <city>Gouda</city>
        <zip>2803 HH</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diakonessenhuis Leiden</name>
      <address>
        <city>Leiden</city>
        <zip>2334 CK</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ikazia Hospital</name>
      <address>
        <city>Rotterdam</city>
        <zip>3083 AN</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 23, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>August 28, 2018</last_update_submitted>
  <last_update_submitted_qc>August 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Population Health Research Institute</investigator_affiliation>
    <investigator_full_name>Jeff Healey</investigator_full_name>
    <investigator_title>Associate Professor, McMaster University</investigator_title>
  </responsible_party>
  <keyword>atrial fibrillation</keyword>
  <keyword>implantable cardiac monitor</keyword>
  <keyword>left atrial enlargement</keyword>
  <keyword>CHA2DS2 VASc Score</keyword>
  <keyword>cardiovascular risk</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT01694394
org study id: ASSERT-II
nct id: NCT01694394
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The primary objective of the study is to determine the rate of detection of sub-clinical
      atrial fibrillation (≥ 5 minutes)within an average of 12 months following implant of the St.
      Jude Medical Confirm(R) Implantable Cardiac Monitor in patients with known cardiovascular
      risk factors and left atrial enlargement, but without prior AF.
Title of Study Prevalence of Sub-Clinical Atrial Fibrillation Using an Implantable Cardiac
      Monitor in Patients with Cardiovascular Risk Factors (ASSERT-II) Short Title ASSERT-II Study
      Sponsor Population Health Research Institute (Grant in Aid from St. Jude Medical, Inc.)
      Principal Investigators Dr. J. Healey, Dr. S. Connolly, Dr. M. Alings Central Coordinating
      Centre Population Health Research Institute Recruitment and Participating Clinical Sites 250
      patients from approximately 30 Sites Phase/Regulatory Status Phase IV - Cohort Study
      Hypothesis Among elderly patients with cardiovascular risk factors and a left atrial diameter
      ≥ 4.4 cm, but without prior clinical AF, an implanted continuous ECG monitor (St. Jude
      Medical Confirm® Implantable Cardiac Monitor) will detect subclinical AF (≥ 5 minutes in
      duration) in 12% or more of patients during an average follow-up of 12 months.

      Study Objectives

      Primary Objectives:

      1. To determine the rate of detection of sub-clinical atrial AF (≥ 5 minutes) within an
      average of 12 months following implant of the St. Jude Medical Confirm® Implantable Cardiac
      Monitor in patients with known cardiovascular risk factors and left atrial enlargement, but
      without prior AF.

      Secondary Objectives

        1. To determine if the incidence of sub-clinical AF is higher among patients whose left
           atrial volume is above the median value observed in this study.

        2. To determine the relationship between left atrial volume (continuous variable) and the
           risk of sub-clinical AF.

        3. To evaluate other potential predictors of sub-acute AF in this population including:
           baseline troponin-T, baseline NT-pro-BNP as well as clinical and other echocardiographic
           parameters.

        4. To develop a preliminary economic analysis to evaluate the potential cost-effectiveness
           of screening this patient population with an Implantable Cardiac Monitor as a means of
           preventing stroke.

      Study Design Cohort study to determine the prevalence of sub-clinical AF in an elderly
      population with common cardiovascular risk factors, such as hypertension and diabetes.
      Patients with echocardiographic evidence of atrial enlargement will be enrolled and have the
      St. Jude Medical Confirm® Implantable Cardiac Monitor (Confirm® ICM) subcutaneously
      implanted. To reduce costs, in most cases the implant will be done in conjunction with other
      planned surgery or heart catheterization.

      PHRI: CONFIDENTIAL Final Version 2.0:2012-06-18 Page 4 of 24 Participants/Study Duration
      Total of 250 participants will be enrolled over 16 months. The last patient enrolled will
      have 9 months of follow-up, for a total study duration of approximately 25 months. Clinic
      visits will occur at enrolment and months 3, 6 and 9. A final visit will take place at 18
      months of follow-up, or after the last patient enrolled has been followed for 9 months
      (whichever comes first).

      Study Population Patients with known cardiovascular risk factors and left atrial enlargement,
      with no prior documented AF.

      Intervention St. Jude Medical Confirm® Implantable Cardiac Monitor (Confirm® ICM) Enrollment
      and Follow-up Eligible and consenting patients will be enrolled and have the Confirm® ICM
      implanted. The implant may take place in conjunction with pre-planned non-cardiac surgery,
      heart catheterization, or as a stand-alone procedure. Follow-up visits will occur at month 3,
      6 and 9. A final visit will take place at 18 months of follow-up, or after the last patient
      enrolled has been followed for 9 months (whichever comes first).

      Assessment of Outcome Events An independent central adjudication committee comprised of
      arrhythmia experts will evaluate device-detected AF episodes.

      Statistical Methodology Determine the incidence of sub-clinical atrial AF (≥ 5 minutes) using
      the Confirm® ICM.

      Date of Protocol June 18, 2012
observational model: Cohort
time perspective: Prospective
measure: First atrial fibrillation episode at least 5 minutes in duration
time frame: over maximum follow-up of 18 months
description: incidence of atrial fibrillation detected by continuous monitoring by an implantable cardiac monitor
arm group label: Cohort
description: Single arm cohort will receive a St. Jude Medical Implantable Cardiac Monitor (Confirm ICM model 2102) for continuous monitoring over the study follow-up period to determine incidence of sub-clinical atrial fibrillation.
intervention type: Device
intervention name: Implantable Cardiac Monitor (Confirm ICM model 2102)
description: Patients who meet the study criteria will be implanted with a St. Jude Medical Confirm Implantable Cardiac Monitor (Confirm ICM) model 2102 or other St. Jude Medical ICM with the same capabilities.
arm group label: Cohort
other name: St. Jude Medical Confirm ICM model 2102
Blood will be collected for NT-ProBNP and hs-Troponin-T
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Jeff Healey, M.D.
role: Principal Investigator
affiliation: Population Health Research Institute
last name: Stuart Connolly, M.D.
role: Principal Investigator
affiliation: Population Health Research Institute
last name: Marco Alings, M.D.
role: Principal Investigator
affiliation: Working group Cardiovascular research Netherlands
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Population Health Research Institute
investigator full name: Jeff Healey
investigator title: Associate Professor, McMaster University
mesh term: Atrial Fibrillation
sharing ipd: Undecided