<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/NCT03803969</url>
  </required_header>
  <id_info>
    <org_study_id>ABT-CIP-10250 Ver. A.1</org_study_id>
    <nct_id>NCT03803969</nct_id>
  </id_info>
  <brief_title>ConfirmRxTM: Posture and Activity</brief_title>
  <official_title>ConfirmRxTM: Effects of Patient Posture and Physical Activity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Devices</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>
      Insertable Cardiac Monitor's (ICM's) such as Confirm Rx™ are leadless devices implanted for&#xD;
      long-term heart rhythm monitoring in the diagnosis and management of clinical conditions such&#xD;
      as recurrent unexplained syncope, cryptogenic stroke, ventricular arrhythmias and monitoring&#xD;
      atrial fibrillations (AF) post ablation. There is limited data on variations seen in signal&#xD;
      sensing with changes in physical activity and posture. This single arm, non-randomized,&#xD;
      open-label, multi-center, clinical investigation of 100 subjects is designed to characterise&#xD;
      the safety and performance of Confirm RxTM by assessing quality of signal attained from the&#xD;
      device with changes in posture and physical activity at implant and 30days post procedure.&#xD;
      The study is also intended to assess gross migrations of the device at 30days post implant.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Syncope is a condition that has vexed cardiologists worldwide due to its elusive nature.&#xD;
      Often a third of patients with syncope remain undiagnosed despite assessments by&#xD;
      multidisciplinary teams and the availability of various screening techniques such as&#xD;
      electrocardiography, 24-h Holter monitoring, carotid sinus massage, echocardiography,&#xD;
      exercise testing, head-up tilt test, and electrophysiological studies. Recently, ICM's have&#xD;
      been developed to continuously monitor heart rhythm and thus aid in the diagnoses and&#xD;
      management of clinical conditions such as ventricular arrhythmias, cryptogenic stroke,&#xD;
      recurrent unexplained syncope and for monitoring atrial fibrillations (AF) post ablation.&#xD;
      ICM's such as Confirm Rx from Abbott are leadless devices that detect arrhythmias largely&#xD;
      depending on sensing of changes in R-R interval and R wave amplitude in the ECG signal.&#xD;
      Whilst ICM's have been helpful in detecting arrhythmias in up to 40% of these patients with&#xD;
      unexplained syncope, there is paucity of data regarding changes in signal quality with&#xD;
      variations in body posture, physical activity and device movements that could potentially&#xD;
      have effects on ECG signal and thus event detection. To this extent, this is an Abbott&#xD;
      sponsored prospective, single arm, non-randomized, open-label, multi-center, clinical trial&#xD;
      of 100 subjects designed to characterize the safety and performance of Confirm Rx™ in&#xD;
      relation to physical activity and posture in these subjects with unexplained syncope.&#xD;
&#xD;
      ConfirmRx™ has come a long way since its inception with a significant reduction in size (78%&#xD;
      reduction by volume) that has led to relatively simple insertion procedures through a small&#xD;
      skin incision. The less complicated insertion process permits the insertion procedure to take&#xD;
      place in settings besides operating rooms and furthermore, smaller devices are associated&#xD;
      with significantly lower incidence of infections. We believe that this study will add to&#xD;
      growing body of evidence of the efficacy of ConfirmRx.&#xD;
&#xD;
      The primary objective of this clinical investigation is to characterise the safety and&#xD;
      performance of the Confirm Rx™ Insertable Cardiac Monitor (ICM) by assessing quality of&#xD;
      signal attained from device post implant with changes in posture and physical activity at&#xD;
      implant and 30days post procedure.&#xD;
&#xD;
      Primary Endpoints&#xD;
&#xD;
        -  Changes in R-wave amplitudes at time of insertion and 30 days post-insertion.&#xD;
&#xD;
        -  Changes in R-wave amplitude with below defined movements at time of insertion, and&#xD;
           30days post-insertion.&#xD;
&#xD;
      To identify any gross migration of Confirm Rx device 30 days following implant. Secondary&#xD;
      Endpoints&#xD;
&#xD;
        -  Change in measured distance/position of scar relative to distance from left lateral&#xD;
           sternal border at baseline and 30 days&#xD;
&#xD;
        -  Measurement of tip of device from left lateral sternal border&#xD;
&#xD;
        -  Deviation of proximal tip of device from scar compared to baseline&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 30, 2018</start_date>
  <completion_date type="Anticipated">October 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This is a prospective, single arm, unblinded, non-randomized, open-label, multi-center, post-market clinical investigation.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Characterisation of the safety and performance of Confirm Rx™ with changes in posture and physical activity at implant and 30days post procedure</measure>
    <time_frame>30+15 days post procedure</time_frame>
    <description>Patient performs defined movements post insertion of device and assessments are made on the Merlin Programmer. These are repeated 30+15 days post procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identification of any gross migration of Confirm Rx device 30 days following implant</measure>
    <time_frame>30+15 days post procedure</time_frame>
    <description>Measurements of location of the device is recorded post procedure and then measured again 30+15 days post procedure</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Syncope</condition>
  <condition>Cryptogenic Stroke</condition>
  <arm_group>
    <arm_group_label>ConfirmRx (Insertable Cardiac Monitor)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This is a single arm study where in patients with an approved indication for a cardiac monitor will receive a ConfirmRx Device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ConfirmRx (Insertable Cardiac Monitor)</intervention_name>
    <description>This study is designed to characterise the safety and performance of the ConfirmRx device by assessing quality of signal attained from the device with changes in posture and physical activity at implant and 30days post procedure. The study is also intended to assess gross migrations of the device at 30days post implant.</description>
    <arm_group_label>ConfirmRx (Insertable Cardiac Monitor)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Eligible patients will meet all the following:&#xD;
&#xD;
          1. Subjects are 18 years of age or older, or of legal age to give informed consent&#xD;
             specific to state and national law.&#xD;
&#xD;
          2. Subject must provide written informed consent prior to any clinical investigation&#xD;
             related procedure.&#xD;
&#xD;
          3. Have an approved indication for continuous arrhythmia monitoring with an Insertable&#xD;
             Cardiac Monitor.&#xD;
&#xD;
          4. Should be willing and able to comply with the prescribed follow-up tests and schedule&#xD;
             of evaluations.&#xD;
&#xD;
          5. Female subjects of child-bearing potential should have a negative pregnancy test done&#xD;
             within 7 days prior to the index procedure per site standard test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will be excluded if they meet any of the following:&#xD;
&#xD;
          1. Subject has previously received an Insertable Cardiac Monitor.&#xD;
&#xD;
          2. Subject is currently enrolled or intend to participate in another clinical&#xD;
             investigation, which could confound the results of this trial during this clinical&#xD;
             study as determined by the sponsor.&#xD;
&#xD;
          3. Pregnant or nursing subjects and those who plan pregnancy during the clinical&#xD;
             investigation follow-up period.&#xD;
&#xD;
          4. Presence of other anatomic or comorbid conditions, or other medical, social, or&#xD;
             psychological conditions that, in the investigator's opinion, could limit the&#xD;
             subject's ability to participate in the clinical investigation or to comply with&#xD;
             follow-up requirements, or impact the scientific soundness of the clinical&#xD;
             investigation results.&#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>Stephen Pavia, MBBS, FRACP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundacion GenesisCare</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sinny Delacroix, MD, PhD</last_name>
    <phone>61 8 8202 6651</phone>
    <email>sinny.delacroix@abbott.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Luke C McSpadden, PhD</last_name>
    <phone>+1 818 493 3720</phone>
    <email>luke.mcspadden@abbott.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Wesley Hospital</name>
      <address>
        <city>Auchenflower</city>
        <state>Queensland</state>
        <zip>4066</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sonia Nelson</last_name>
      <phone>61 7 3858 8918</phone>
      <email>sonia.nelson@genesiscare.com</email>
    </contact>
    <investigator>
      <last_name>Stephen Pavia</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Friendly Society Private Hospital</name>
      <address>
        <city>Bundaberg</city>
        <state>Queensland</state>
        <zip>4670</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kassandra Howes</last_name>
      <phone>61 7 4199 7300</phone>
      <email>kassandra.howes@genesiscare.com</email>
    </contact>
    <investigator>
      <last_name>Andre Conradie</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Greenslopes Private Hospital</name>
      <address>
        <city>Greenslopes</city>
        <state>Queensland</state>
        <zip>4120</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sonia Nelson</last_name>
      <phone>61 7 3858 8918</phone>
      <email>sonia.nelson@genesiscare.com</email>
    </contact>
    <investigator>
      <last_name>Anders Taylor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St Andrews Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Renae Deans, MD, PhD</last_name>
      <phone>61 8 8202 6654</phone>
      <email>renae.deans@genesiscare.com</email>
    </contact>
    <investigator>
      <last_name>Glenn Young</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Warringal Private Hospital</name>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michelle Ord</last_name>
      <phone>61 3 8467 5900</phone>
      <email>michelle.ord@genesiscare.com</email>
    </contact>
    <investigator>
      <last_name>David O'Donnell</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Valley Private Hospital</name>
      <address>
        <city>Mulgrave</city>
        <state>Victoria</state>
        <zip>3170</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Michelle Ord</last_name>
      <phone>61 3 8467 5900</phone>
      <email>michelle.ord@genesiscare.com</email>
    </contact>
    <investigator>
      <last_name>Matthew Swale</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St John of God Murdoch Hospital</name>
      <address>
        <city>Murdoch</city>
        <state>Western Australia</state>
        <zip>6150</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joy Vibert</last_name>
      <phone>61 8 9400 6232</phone>
      <email>joy.vibert@genesiscare.com</email>
    </contact>
    <investigator>
      <last_name>Vincent Paul</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mount Hospital</name>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>6000</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joy Vibert</last_name>
      <phone>61 8 9400 6232</phone>
      <email>joy.vibert@genesiscare.com</email>
    </contact>
    <investigator>
      <last_name>Benjamin King</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 5, 2023</last_update_submitted>
  <last_update_submitted_qc>January 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Syncope</keyword>
  <keyword>Cryptogenic Stroke</keyword>
  <keyword>Physical activity</keyword>
  <keyword>Posture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syncope</mesh_term>
    <mesh_term>Ischemic Stroke</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/NCT03803969
org study id: ABT-CIP-10250 Ver. A.1
nct id: NCT03803969
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Insertable Cardiac Monitor's (ICM's) such as Confirm Rx™ are leadless devices implanted for
      long-term heart rhythm monitoring in the diagnosis and management of clinical conditions such
      as recurrent unexplained syncope, cryptogenic stroke, ventricular arrhythmias and monitoring
      atrial fibrillations (AF) post ablation. There is limited data on variations seen in signal
      sensing with changes in physical activity and posture. This single arm, non-randomized,
      open-label, multi-center, clinical investigation of 100 subjects is designed to characterise
      the safety and performance of Confirm RxTM by assessing quality of signal attained from the
      device with changes in posture and physical activity at implant and 30days post procedure.
      The study is also intended to assess gross migrations of the device at 30days post implant.
Syncope is a condition that has vexed cardiologists worldwide due to its elusive nature.
      Often a third of patients with syncope remain undiagnosed despite assessments by
      multidisciplinary teams and the availability of various screening techniques such as
      electrocardiography, 24-h Holter monitoring, carotid sinus massage, echocardiography,
      exercise testing, head-up tilt test, and electrophysiological studies. Recently, ICM's have
      been developed to continuously monitor heart rhythm and thus aid in the diagnoses and
      management of clinical conditions such as ventricular arrhythmias, cryptogenic stroke,
      recurrent unexplained syncope and for monitoring atrial fibrillations (AF) post ablation.
      ICM's such as Confirm Rx from Abbott are leadless devices that detect arrhythmias largely
      depending on sensing of changes in R-R interval and R wave amplitude in the ECG signal.
      Whilst ICM's have been helpful in detecting arrhythmias in up to 40% of these patients with
      unexplained syncope, there is paucity of data regarding changes in signal quality with
      variations in body posture, physical activity and device movements that could potentially
      have effects on ECG signal and thus event detection. To this extent, this is an Abbott
      sponsored prospective, single arm, non-randomized, open-label, multi-center, clinical trial
      of 100 subjects designed to characterize the safety and performance of Confirm Rx™ in
      relation to physical activity and posture in these subjects with unexplained syncope.

      ConfirmRx™ has come a long way since its inception with a significant reduction in size (78%
      reduction by volume) that has led to relatively simple insertion procedures through a small
      skin incision. The less complicated insertion process permits the insertion procedure to take
      place in settings besides operating rooms and furthermore, smaller devices are associated
      with significantly lower incidence of infections. We believe that this study will add to
      growing body of evidence of the efficacy of ConfirmRx.

      The primary objective of this clinical investigation is to characterise the safety and
      performance of the Confirm Rx™ Insertable Cardiac Monitor (ICM) by assessing quality of
      signal attained from device post implant with changes in posture and physical activity at
      implant and 30days post procedure.

      Primary Endpoints

        -  Changes in R-wave amplitudes at time of insertion and 30 days post-insertion.

        -  Changes in R-wave amplitude with below defined movements at time of insertion, and
           30days post-insertion.

      To identify any gross migration of Confirm Rx device 30 days following implant. Secondary
      Endpoints

        -  Change in measured distance/position of scar relative to distance from left lateral
           sternal border at baseline and 30 days

        -  Measurement of tip of device from left lateral sternal border

        -  Deviation of proximal tip of device from scar compared to baseline
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is a prospective, single arm, unblinded, non-randomized, open-label, multi-center, post-market clinical investigation.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Characterisation of the safety and performance of Confirm Rx™ with changes in posture and physical activity at implant and 30days post procedure
time frame: 30+15 days post procedure
description: Patient performs defined movements post insertion of device and assessments are made on the Merlin Programmer. These are repeated 30+15 days post procedure
measure: Identification of any gross migration of Confirm Rx device 30 days following implant
time frame: 30+15 days post procedure
description: Measurements of location of the device is recorded post procedure and then measured again 30+15 days post procedure
arm group label: ConfirmRx (Insertable Cardiac Monitor)
arm group type: Other
description: This is a single arm study where in patients with an approved indication for a cardiac monitor will receive a ConfirmRx Device.
intervention type: Device
intervention name: ConfirmRx (Insertable Cardiac Monitor)
description: This study is designed to characterise the safety and performance of the ConfirmRx device by assessing quality of signal attained from the device with changes in posture and physical activity at implant and 30days post procedure. The study is also intended to assess gross migrations of the device at 30days post implant.
arm group label: ConfirmRx (Insertable Cardiac Monitor)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stephen Pavia, MBBS, FRACP
role: Principal Investigator
affiliation: Fundacion GenesisCare
last name: Sinny Delacroix, MD, PhD
phone: 61 8 8202 6651
email: sinny.delacroix@abbott.com
last name: Luke C McSpadden, PhD
phone: +1 818 493 3720
email: luke.mcspadden@abbott.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Australia
responsible party type: Sponsor
mesh term: Syncope
mesh term: Ischemic Stroke
sharing ipd: No