<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/NCT03810820</url>
  </required_header>
  <id_info>
    <org_study_id>REdireCT TAVI</org_study_id>
    <nct_id>NCT03810820</nct_id>
  </id_info>
  <brief_title>Remote ECG Monitoring of TAVI Patients</brief_title>
  <official_title>Remote ECG Monitoring to Reduce Complications Following Transcatheter Aortic Valve Implantations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Population Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hamilton Health Sciences Corporation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Southlake Regional Health Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>M-Health Solutions</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Population Health Research Institute</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>
      After surgery, patients who undergo transcatheter aortic valve implantation (TAVI) are at&#xD;
      risk of developing cardiac arrhythmias such as heart blocks and atrial fibrillation. Current&#xD;
      practice is to monitor TAVI patients in hospital for 2-8 days post procedure using scarce and&#xD;
      expensive hospital telemetry beds. This study will use a new monitoring service called mobile&#xD;
      Cardiac Arrhythmia Diagnostics Service (m-CARDS) to risk stratify patient pre-TAVI and&#xD;
      provide an added layer of monitoring that would support earlier discharge of suitably&#xD;
      identified patients 24-hours post TAVI. The study will assess whether this strategy will&#xD;
      significantly reduce the pressure on hospital resources while improving patient outcomes and&#xD;
      experience.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aortic stenosis (AS), the most common valvular heart disease, occurs when there is a&#xD;
      narrowing of the aortic valve opening. New transcatheter aortic valve implantation (TAVI,&#xD;
      also called transcatheter aortic valve replacement [TAVR]), is a minimally invasive surgical&#xD;
      procedure that is rapidly expanding as the dominant treatment modality for elderly patients&#xD;
      with AS. Approximately 1000 patients will undergo TAVR surgery in Ontario in fiscal year&#xD;
      2018-2019 and that number is expected to increase to ~80% of all valve replacement surgery&#xD;
      within the next 5 years.&#xD;
&#xD;
      Patients that undergo TAVI are at risk of developing cardiac arrhythmias such as heart block&#xD;
      and atrial fibrillation and many are routinely monitored in-hospital for 5-8 days&#xD;
      post-surgery. Currently, this monitoring is done using scarce and expensive hospital&#xD;
      telemetry beds.&#xD;
&#xD;
      This study uses a novel clinical pathway including remote monitoring pre- and post-TAVI using&#xD;
      a new service called mobile Cardiac Arrhythmia Diagnostics Service (m-CARDS™). m-CARDS™&#xD;
      consists of a patient cardiac monitoring device that transmits cardiac data in real time to a&#xD;
      centralized center. Patients wearing the device can remain in the comfort of their own home&#xD;
      while being monitored remotely. The monitoring device is Health Canada approved and has been&#xD;
      used extensively. Because it is highly sensitive to cardiac arrhythmias, including all levels&#xD;
      of heart block, it is ideally suited for this type of monitoring.&#xD;
&#xD;
      If this pathway is adopted across all centres it will significantly reduce the pressure on&#xD;
      hospital resources while at the same time improve the patient experience, enabling them to&#xD;
      get home sooner. Hospital telemetry is very expensive. Reducing the length of stay from 2-8&#xD;
      days on average to 24hr for many patients would represent cost savings to the hospitals and&#xD;
      province.&#xD;
&#xD;
      While some studies show that patients could be discharged earlier, there is still significant&#xD;
      variability in adopting a short length of stay post-TAVI due to a perceived need for&#xD;
      inpatient monitoring and lack of adequate knowledge and data on feasibility of remote&#xD;
      outpatient monitoring.&#xD;
&#xD;
      In addition, the pre-TAVR monitoring will enhance our ability to predict and plan for&#xD;
      interventions such as permanent pacemaker implantation. The primary objective of this project&#xD;
      will be to facilitate the implementation of this monitoring technology into a busy tertiary&#xD;
      care setting and better understand the conditions necessary for successful implementation.&#xD;
      This will be achieved through ongoing stakeholder engagement (patient, provider, and hospital&#xD;
      administrators) at all stages of the implementation program and close evaluation of quality&#xD;
      metrics to ensure fidelity of the m-CARDS™ system.&#xD;
&#xD;
      Overall, implementation of this system is expected to impact the following levels of the&#xD;
      health care system:&#xD;
&#xD;
      i) Patient-Level: Improved quality of life through &quot;better care closer to home&quot; facilitated&#xD;
      by physician supported monitoring before TAVI and post-TAVI discharge from hospital.&#xD;
&#xD;
      ii) Provider-Level/Organizational-Level: Integrate the m-CARDS™ system into a busy TAVI&#xD;
      clinical care pathway that can be adapted at other TAVI centres and ensure&#xD;
      physician/administrator engagement/confidence in this novel technology.&#xD;
&#xD;
      iii) System-Level: Reduced (1) hospital length of stay and associated costs, (2) readmissions&#xD;
      and unplanned medical visits, and (3) likelihood of hospital acquired infections.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 20, 2018</start_date>
  <completion_date type="Anticipated">July 30, 2021</completion_date>
  <primary_completion_date type="Actual">July 30, 2020</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>Prospective cohort of consecutive patients booked for outpatient TAVI.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility: Recruitment rate</measure>
    <time_frame>End of study (Approximately Month 24)</time_frame>
    <description>To achieve recruitment of at least 80% of eligible patients and to describe reasons for non-participation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility: Participant adherence to monitoring pre-TAVI</measure>
    <time_frame>End of pre-TAVI monitoring period (Day 14)</time_frame>
    <description>To achieve patient level adherence to monitoring at least 80% of the expected time (total # of days (hours) of loop monitoring pre-TAVI).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility: Participant adherence to monitoring post-TAVI</measure>
    <time_frame>End of post-TAVI monitoring period (approximately Month 2 dependent on scheduling of TAVI procedure)</time_frame>
    <description>To achieve patient level adherence to monitoring at least 80% of the expected time (total # of days (hours) of loop monitoring post-TAVI).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility: Requirement for PPM pre-TAVI</measure>
    <time_frame>End of pre-TAVI monitoring period (Day 14)</time_frame>
    <description>Pre-TAVI identification of at least 5-10% of the cohort population who would need permanent pacemaker (either heart block or characteristics high risk for heart block).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility: Participant adherence to post-TAVI monitoring protocol</measure>
    <time_frame>End of post-TAVI monitoring period (approximately Month 2)</time_frame>
    <description>To facilitate complete success with post-discharge monitoring in &gt; 80% of recruited and eligible participants (wearing monitor on same day as discharge for at least one week).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility: Timeliness of medical assessment of participants with &quot;serious&quot; arrhythmia identified on monitor pre-TAVI</measure>
    <time_frame>End of pre-TAVI monitoring period (Day 14)</time_frame>
    <description>To have 80% rate of medical assessment within 24 hours for any recruited and eligible patients with identified &quot;serious&quot; arrhythmia pre-TAVI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility: Timeliness of medical assessment of participants with &quot;serious&quot; arrhythmia identified on monitor post-TAVI</measure>
    <time_frame>End of post-TAVI monitoring period (approximately Month 2)</time_frame>
    <description>To have 80% rate of medical assessment within 24 hours for any recruited and eligible patients with identified &quot;serious&quot; arrhythmia post-TAVI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Experience Questionnaire</measure>
    <time_frame>30-day follow-up</time_frame>
    <description>Survey of patient experience related to shortened length of hospital stay due to remote ECG monitoring via loop monitor and experience of care given when there are clinical findings on loop monitor</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Team Experience Questionnaire</measure>
    <time_frame>30-day follow-up</time_frame>
    <description>Survey of clinical team experience related to implementation of a new clinical pathway for pre- and post-procedure care of TAVI patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participant or clinical team activations based on monitor findings pre-TAVI</measure>
    <time_frame>End of pre-TAVI monitoring period (Day 14)</time_frame>
    <description>Total number of clinical team and participant activations, along with a) Inappropriate clinical team and participant activations - clinical team is activated but no patient intervention is undertaken and b) Inappropriate negative activations - arrhythmia event is seen on loop monitoring but clinical team is not activated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participant or clinical team activations based on monitor findings post-TAVI</measure>
    <time_frame>End of post-TAVI monitoring period (approximately Month 2)</time_frame>
    <description>Total number of clinical team and participant activations, along with a) Inappropriate clinical team and participant activations - clinical team is activated but no patient intervention is undertaken and b) Inappropriate negative activations - arrhythmia event is seen on loop monitoring but clinical team is not activated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time from identification of findings on remote monitor to clinical team activation for pre-TAVI findings.</measure>
    <time_frame>End of pre-TAVI monitoring period (Day 14)</time_frame>
    <description>Time from when a finding is noted on remote monitor to the time the clinical team is activated to assess and intervene with the participant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time from identification of findings on remote monitor to clinical team activation for post-TAVI findings.</measure>
    <time_frame>End of post-TAVI monitoring period (approximately Month 2)</time_frame>
    <description>Time from when a finding is noted on remote monitor to the time the clinical team is activated to assess and intervene with the participant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay post-TAVI</measure>
    <time_frame>Month 2 (approximate, dependent on scheduling of TAVI procedure)</time_frame>
    <description>Duration of hospitalization post-TAVI procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arrhythmia-related unplanned re-hospitalization</measure>
    <time_frame>30-day post-TAVI follow-up assessment</time_frame>
    <description>Unscheduled hospitalization or prolongation of hospitalization for heart rhythm reasons or PPM insertion pre- or post-TAVI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New onset of advanced AVB pre-TAVI</measure>
    <time_frame>End of pre-TAVI monitoring period (Day 14)</time_frame>
    <description>Defined as 2:1 second-degree or higher AVB.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New onset of advanced AVB post-TAVI</measure>
    <time_frame>End of post-TAVI monitoring period (approximately Month 2)</time_frame>
    <description>Defined as 2:1 second-degree or higher AVB.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New onset paroxysmal AF pre-TAVI</measure>
    <time_frame>End of pre-TAVI monitoring period (Day 14)</time_frame>
    <description>Defined as any irregular atrial rhythm with absence of consistent P waves lasting &gt; 6 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New onset paroxysmal AF post-TAVI</measure>
    <time_frame>End of post-TAVI monitoring period (approximately Month 2)</time_frame>
    <description>Defined as any irregular atrial rhythm with absence of consistent P waves lasting &gt; 6 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New onset atrial tachycardia pre-TAVI</measure>
    <time_frame>End of pre-TAVI monitoring period (Day 14)</time_frame>
    <description>Defined as period of sudden rapid and regular atrial rhythm with identifiable P waves.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New onset atrial tachycardia post-TAVI</measure>
    <time_frame>End of post-TAVI monitoring period (approximately Month 2)</time_frame>
    <description>Defined as period of sudden rapid and regular atrial rhythm with identifiable P waves.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New onset NSVT pre-TAVI</measure>
    <time_frame>End of pre-TAVI monitoring period (Day 14)</time_frame>
    <description>Defined as runs of &gt;/= 3 ventricular beats at a heart rate of &gt; 100 bpm lasting &lt; 30 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New onset NSVT post-TAVI</measure>
    <time_frame>End of post-TAVI monitoring period (approximately Month 2)</time_frame>
    <description>Defined as runs of &gt;/= 3 ventricular beats at a heart rate of &gt; 100 bpm lasting &lt; 30 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New sustained VT pre-TAVI</measure>
    <time_frame>End of pre-TAVI monitoring period (Day 14)</time_frame>
    <description>Defined as ventricular runs lasting &gt;/= 30 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New sustained VT post-TAVI</measure>
    <time_frame>End of post-TAVI monitoring period (approximately Month 2)</time_frame>
    <description>Defined as ventricular runs lasting &gt;/= 30 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe bradycardia pre-TAVI</measure>
    <time_frame>End of pre-TAVI monitoring period (Day 14)</time_frame>
    <description>Defined as heart rate &lt; 40 bpm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe bradycardia post-TAVI</measure>
    <time_frame>End of post-TAVI monitoring period (approximately Month 2)</time_frame>
    <description>Defined as heart rate &lt; 40 bpm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New onset persistent LBBB</measure>
    <time_frame>Month 2 (approximate, dependent on scheduling of TAVI procedure)</time_frame>
    <description>Defined as new onset LBBB after TAVI that persisted at hospital discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temporary PM required post-TAVI</measure>
    <time_frame>Month 2 (approximate, depending on scheduling of TAVI procedure)</time_frame>
    <description>Temporary PM not removed within 4 hours of completion of leaving procedure room.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total number of PPM implantations</measure>
    <time_frame>30-day post-TAVI follow-up</time_frame>
    <description>Total number of PPM implantations that are either planned (if the inciting heart rhythm was identified on monitor and implantation of PPM was arranged) or unplanned (if the monitor was not the initiating factor).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total hospitalization days up to 30 days post-TAVI</measure>
    <time_frame>30-day post-TAVI follow-up</time_frame>
    <description>Number of days in hospital after discharge from TAVI procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergency Department (ED) Visits</measure>
    <time_frame>30-day post-TAVI follow-up</time_frame>
    <description>Number of ED visits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care utilization costs</measure>
    <time_frame>30-day post-TAVI follow-up</time_frame>
    <description>Costs associated with length of stay, ED use, re-admission to hospital and outpatient clinic visits will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Syncope requiring medical assessment</measure>
    <time_frame>30-day post-TAVI follow-up</time_frame>
    <description>Any incident of syncope that requires medical assessment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Cardiac Valve Disease</condition>
  <condition>Aortic Valve Stenosis</condition>
  <arm_group>
    <arm_group_label>Outpatient TAVI</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Consecutive patients scheduled for outpatient TAVI.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>mobile Cardiac Arrhythmia Diagnostics Service (m-CARDS)</intervention_name>
    <description>A wearable cardiac monitoring device is provided to patients pre- and post-TAVI. The monitor transmits cardiac data in real time to the m-CARDs team. Cardiac abnormalities are reported to the clinical team who then assess the abnormality and intervene as clinically necessary.</description>
    <arm_group_label>Outpatient TAVI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients selected for TAVI procedure that do not meet exclusion criteria and&#xD;
             provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with prior PPM or ICD&#xD;
&#xD;
          -  Patient in-hospital awaiting TAVI&#xD;
&#xD;
          -  Resting 12-lead ECG shows first degree AV block, plus LAHB plus RBBB; high grade 2nd&#xD;
             or 3rd degree heart block&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Madhu Natarajan, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Population Health Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hamilton Health Sciences Corporation - Hamilton General Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8L 2X2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>November 2, 2018</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>February 3, 2021</last_update_submitted>
  <last_update_submitted_qc>February 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TAVR</keyword>
  <keyword>TAVI</keyword>
  <keyword>Heart block</keyword>
  <keyword>Atrial fibrillation</keyword>
  <keyword>Cardiac arrhythmias</keyword>
  <keyword>Permanent pacemaker</keyword>
  <keyword>Remote cardiac monitoring</keyword>
  <keyword>Loop monitor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
    <mesh_term>Heart Valve Diseases</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/NCT03810820
org study id: REdireCT TAVI
nct id: NCT03810820
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
After surgery, patients who undergo transcatheter aortic valve implantation (TAVI) are at
      risk of developing cardiac arrhythmias such as heart blocks and atrial fibrillation. Current
      practice is to monitor TAVI patients in hospital for 2-8 days post procedure using scarce and
      expensive hospital telemetry beds. This study will use a new monitoring service called mobile
      Cardiac Arrhythmia Diagnostics Service (m-CARDS) to risk stratify patient pre-TAVI and
      provide an added layer of monitoring that would support earlier discharge of suitably
      identified patients 24-hours post TAVI. The study will assess whether this strategy will
      significantly reduce the pressure on hospital resources while improving patient outcomes and
      experience.
Aortic stenosis (AS), the most common valvular heart disease, occurs when there is a
      narrowing of the aortic valve opening. New transcatheter aortic valve implantation (TAVI,
      also called transcatheter aortic valve replacement [TAVR]), is a minimally invasive surgical
      procedure that is rapidly expanding as the dominant treatment modality for elderly patients
      with AS. Approximately 1000 patients will undergo TAVR surgery in Ontario in fiscal year
      2018-2019 and that number is expected to increase to ~80% of all valve replacement surgery
      within the next 5 years.

      Patients that undergo TAVI are at risk of developing cardiac arrhythmias such as heart block
      and atrial fibrillation and many are routinely monitored in-hospital for 5-8 days
      post-surgery. Currently, this monitoring is done using scarce and expensive hospital
      telemetry beds.

      This study uses a novel clinical pathway including remote monitoring pre- and post-TAVI using
      a new service called mobile Cardiac Arrhythmia Diagnostics Service (m-CARDS™). m-CARDS™
      consists of a patient cardiac monitoring device that transmits cardiac data in real time to a
      centralized center. Patients wearing the device can remain in the comfort of their own home
      while being monitored remotely. The monitoring device is Health Canada approved and has been
      used extensively. Because it is highly sensitive to cardiac arrhythmias, including all levels
      of heart block, it is ideally suited for this type of monitoring.

      If this pathway is adopted across all centres it will significantly reduce the pressure on
      hospital resources while at the same time improve the patient experience, enabling them to
      get home sooner. Hospital telemetry is very expensive. Reducing the length of stay from 2-8
      days on average to 24hr for many patients would represent cost savings to the hospitals and
      province.

      While some studies show that patients could be discharged earlier, there is still significant
      variability in adopting a short length of stay post-TAVI due to a perceived need for
      inpatient monitoring and lack of adequate knowledge and data on feasibility of remote
      outpatient monitoring.

      In addition, the pre-TAVR monitoring will enhance our ability to predict and plan for
      interventions such as permanent pacemaker implantation. The primary objective of this project
      will be to facilitate the implementation of this monitoring technology into a busy tertiary
      care setting and better understand the conditions necessary for successful implementation.
      This will be achieved through ongoing stakeholder engagement (patient, provider, and hospital
      administrators) at all stages of the implementation program and close evaluation of quality
      metrics to ensure fidelity of the m-CARDS™ system.

      Overall, implementation of this system is expected to impact the following levels of the
      health care system:

      i) Patient-Level: Improved quality of life through "better care closer to home" facilitated
      by physician supported monitoring before TAVI and post-TAVI discharge from hospital.

      ii) Provider-Level/Organizational-Level: Integrate the m-CARDS™ system into a busy TAVI
      clinical care pathway that can be adapted at other TAVI centres and ensure
      physician/administrator engagement/confidence in this novel technology.

      iii) System-Level: Reduced (1) hospital length of stay and associated costs, (2) readmissions
      and unplanned medical visits, and (3) likelihood of hospital acquired infections.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective cohort of consecutive patients booked for outpatient TAVI.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Feasibility: Recruitment rate
time frame: End of study (Approximately Month 24)
description: To achieve recruitment of at least 80% of eligible patients and to describe reasons for non-participation.
measure: Feasibility: Participant adherence to monitoring pre-TAVI
time frame: End of pre-TAVI monitoring period (Day 14)
description: To achieve patient level adherence to monitoring at least 80% of the expected time (total # of days (hours) of loop monitoring pre-TAVI).
measure: Feasibility: Participant adherence to monitoring post-TAVI
time frame: End of post-TAVI monitoring period (approximately Month 2 dependent on scheduling of TAVI procedure)
description: To achieve patient level adherence to monitoring at least 80% of the expected time (total # of days (hours) of loop monitoring post-TAVI).
measure: Feasibility: Requirement for PPM pre-TAVI
time frame: End of pre-TAVI monitoring period (Day 14)
description: Pre-TAVI identification of at least 5-10% of the cohort population who would need permanent pacemaker (either heart block or characteristics high risk for heart block).
measure: Feasibility: Participant adherence to post-TAVI monitoring protocol
time frame: End of post-TAVI monitoring period (approximately Month 2)
description: To facilitate complete success with post-discharge monitoring in > 80% of recruited and eligible participants (wearing monitor on same day as discharge for at least one week).
measure: Feasibility: Timeliness of medical assessment of participants with "serious" arrhythmia identified on monitor pre-TAVI
time frame: End of pre-TAVI monitoring period (Day 14)
description: To have 80% rate of medical assessment within 24 hours for any recruited and eligible patients with identified "serious" arrhythmia pre-TAVI.
measure: Feasibility: Timeliness of medical assessment of participants with "serious" arrhythmia identified on monitor post-TAVI
time frame: End of post-TAVI monitoring period (approximately Month 2)
description: To have 80% rate of medical assessment within 24 hours for any recruited and eligible patients with identified "serious" arrhythmia post-TAVI.
measure: Patient Experience Questionnaire
time frame: 30-day follow-up
description: Survey of patient experience related to shortened length of hospital stay due to remote ECG monitoring via loop monitor and experience of care given when there are clinical findings on loop monitor
measure: Clinical Team Experience Questionnaire
time frame: 30-day follow-up
description: Survey of clinical team experience related to implementation of a new clinical pathway for pre- and post-procedure care of TAVI patients.
measure: Number of participant or clinical team activations based on monitor findings pre-TAVI
time frame: End of pre-TAVI monitoring period (Day 14)
description: Total number of clinical team and participant activations, along with a) Inappropriate clinical team and participant activations - clinical team is activated but no patient intervention is undertaken and b) Inappropriate negative activations - arrhythmia event is seen on loop monitoring but clinical team is not activated.
measure: Number of participant or clinical team activations based on monitor findings post-TAVI
time frame: End of post-TAVI monitoring period (approximately Month 2)
description: Total number of clinical team and participant activations, along with a) Inappropriate clinical team and participant activations - clinical team is activated but no patient intervention is undertaken and b) Inappropriate negative activations - arrhythmia event is seen on loop monitoring but clinical team is not activated.
measure: Time from identification of findings on remote monitor to clinical team activation for pre-TAVI findings.
time frame: End of pre-TAVI monitoring period (Day 14)
description: Time from when a finding is noted on remote monitor to the time the clinical team is activated to assess and intervene with the participant.
measure: Time from identification of findings on remote monitor to clinical team activation for post-TAVI findings.
time frame: End of post-TAVI monitoring period (approximately Month 2)
description: Time from when a finding is noted on remote monitor to the time the clinical team is activated to assess and intervene with the participant.
measure: Hospital length of stay post-TAVI
time frame: Month 2 (approximate, dependent on scheduling of TAVI procedure)
description: Duration of hospitalization post-TAVI procedure.
measure: Arrhythmia-related unplanned re-hospitalization
time frame: 30-day post-TAVI follow-up assessment
description: Unscheduled hospitalization or prolongation of hospitalization for heart rhythm reasons or PPM insertion pre- or post-TAVI.
measure: New onset of advanced AVB pre-TAVI
time frame: End of pre-TAVI monitoring period (Day 14)
description: Defined as 2:1 second-degree or higher AVB.
measure: New onset of advanced AVB post-TAVI
time frame: End of post-TAVI monitoring period (approximately Month 2)
description: Defined as 2:1 second-degree or higher AVB.
measure: New onset paroxysmal AF pre-TAVI
time frame: End of pre-TAVI monitoring period (Day 14)
description: Defined as any irregular atrial rhythm with absence of consistent P waves lasting > 6 seconds.
measure: New onset paroxysmal AF post-TAVI
time frame: End of post-TAVI monitoring period (approximately Month 2)
description: Defined as any irregular atrial rhythm with absence of consistent P waves lasting > 6 seconds.
measure: New onset atrial tachycardia pre-TAVI
time frame: End of pre-TAVI monitoring period (Day 14)
description: Defined as period of sudden rapid and regular atrial rhythm with identifiable P waves.
measure: New onset atrial tachycardia post-TAVI
time frame: End of post-TAVI monitoring period (approximately Month 2)
description: Defined as period of sudden rapid and regular atrial rhythm with identifiable P waves.
measure: New onset NSVT pre-TAVI
time frame: End of pre-TAVI monitoring period (Day 14)
description: Defined as runs of >/= 3 ventricular beats at a heart rate of > 100 bpm lasting < 30 seconds.
measure: New onset NSVT post-TAVI
time frame: End of post-TAVI monitoring period (approximately Month 2)
description: Defined as runs of >/= 3 ventricular beats at a heart rate of > 100 bpm lasting < 30 seconds.
measure: New sustained VT pre-TAVI
time frame: End of pre-TAVI monitoring period (Day 14)
description: Defined as ventricular runs lasting >/= 30 seconds.
measure: New sustained VT post-TAVI
time frame: End of post-TAVI monitoring period (approximately Month 2)
description: Defined as ventricular runs lasting >/= 30 seconds.
measure: Severe bradycardia pre-TAVI
time frame: End of pre-TAVI monitoring period (Day 14)
description: Defined as heart rate < 40 bpm.
measure: Severe bradycardia post-TAVI
time frame: End of post-TAVI monitoring period (approximately Month 2)
description: Defined as heart rate < 40 bpm.
measure: New onset persistent LBBB
time frame: Month 2 (approximate, dependent on scheduling of TAVI procedure)
description: Defined as new onset LBBB after TAVI that persisted at hospital discharge.
measure: Temporary PM required post-TAVI
time frame: Month 2 (approximate, depending on scheduling of TAVI procedure)
description: Temporary PM not removed within 4 hours of completion of leaving procedure room.
measure: Total number of PPM implantations
time frame: 30-day post-TAVI follow-up
description: Total number of PPM implantations that are either planned (if the inciting heart rhythm was identified on monitor and implantation of PPM was arranged) or unplanned (if the monitor was not the initiating factor).
measure: Total hospitalization days up to 30 days post-TAVI
time frame: 30-day post-TAVI follow-up
description: Number of days in hospital after discharge from TAVI procedure.
measure: Emergency Department (ED) Visits
time frame: 30-day post-TAVI follow-up
description: Number of ED visits.
measure: Health care utilization costs
time frame: 30-day post-TAVI follow-up
description: Costs associated with length of stay, ED use, re-admission to hospital and outpatient clinic visits will be calculated.
measure: Syncope requiring medical assessment
time frame: 30-day post-TAVI follow-up
description: Any incident of syncope that requires medical assessment.
arm group label: Outpatient TAVI
arm group type: Other
description: Consecutive patients scheduled for outpatient TAVI.
intervention type: Device
intervention name: mobile Cardiac Arrhythmia Diagnostics Service (m-CARDS)
description: A wearable cardiac monitoring device is provided to patients pre- and post-TAVI. The monitor transmits cardiac data in real time to the m-CARDs team. Cardiac abnormalities are reported to the clinical team who then assess the abnormality and intervene as clinically necessary.
arm group label: Outpatient TAVI
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Madhu Natarajan, M.D.
role: Principal Investigator
affiliation: Population Health Research Institute
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
mesh term: Heart Valve Diseases
sharing ipd: No