<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/NCT03303612</url>
  </required_header>
  <id_info>
    <org_study_id>ICM#2015-1949</org_study_id>
    <nct_id>NCT03303612</nct_id>
  </id_info>
  <brief_title>Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI</brief_title>
  <acronym>COME-TAVI</acronym>
  <official_title>Comparison of a Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach in Patients With a New Left Bundle Branch Block After Transcatheter Aortic Valve Implantation (TAVI) a Bayesian Randomized Trial (COME-TAVI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montreal Heart Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Montreal Heart Institute</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>
      The primary hypothesis of the proposed study is that an electrophysiology-based algorithmic&#xD;
      approach is superior to standard clinical follow-up with 30-day monitoring in reducing the&#xD;
      combined endpoint of syncope, hospitalization, and death in patients in patients with new of&#xD;
      left bundle branch block following transcatheter aortic valve implantation (TAVI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study population consists of pacemaker-free patients that are 18 years or older&#xD;
      undergoing a TAVI with new onset left bundle branch block. Patient consent is required.&#xD;
&#xD;
      Patients meeting the inclusion criteria will be randomized in a 1:1 ratio to one of the&#xD;
      following two groups:&#xD;
&#xD;
      Group 1: electrophysiology-based algorithmic approach&#xD;
&#xD;
      Group 2: standard clinical follow-up with transcutaneous cardiac monitoring.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 15, 2017</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with cardiovascular hospitalization, and/or syncope, and/or death after TAVI.</measure>
    <time_frame>12 months</time_frame>
    <description>This is the number of participants who experienced cardiovascular hospitalizations, and/or syncope, and/or death after TAVI.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with cardiovascular hospitalizations.</measure>
    <time_frame>12 months</time_frame>
    <description>This is the number of participants who were hospitalized for cardiovascular reasons within one-year post-TAVI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with hospitalisations (Total)</measure>
    <time_frame>12 months</time_frame>
    <description>This is the number of participants who were hospitalized one-year post-TAVI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with emergency visits.</measure>
    <time_frame>12 months</time_frame>
    <description>This is the number of participants who had emergency visits after TAVI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants experiencing syncope</measure>
    <time_frame>12 months</time_frame>
    <description>This is the number of participants who experienced syncope after TAVI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness of EP-guided procedure compared to cardiac monitoring [incremental cost effectiveness ratio (ICER)].</measure>
    <time_frame>12 months</time_frame>
    <description>This is the incremental cost effectiveness ratio (ICER) for one strategy compared to the other.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of procedural complications in the group of EP-guided procedure compared to the group of cardiac monitoring.</measure>
    <time_frame>30 days</time_frame>
    <description>This is the number of procedural complications in the group of EP-guided approach compared to cardiac monitoring within 30 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of atrio-ventricular blocks in the group of EP-guided procedure compared to the group of transcutaneous cardiac monitoring.</measure>
    <time_frame>12 months</time_frame>
    <description>This is the number of atrio-ventricular blocks in the EP-guided procedure group compared to the transcutaneous cardiac monitoring group within 12 months of TAVI</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Left Bundle-Branch Block</condition>
  <condition>Aortic Valve Stenosis</condition>
  <arm_group>
    <arm_group_label>EP-based approach/pacemaker implant</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects will undergo an EP study prior to hospital discharge and will receive a pacemaker implantation if the HV interval is ≥65 msec.&#xD;
In the case where the electrical slowdown is not confirmed by the electrophysiological study, the participant will not have a pacemaker implantation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Compared transcutaneous cardiac monitor</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects will undergo a minimum of 72 hour ECG monitoring in hospital and receive transcutaneous monitoring prior to hospital discharge for a duration of 30 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pacemaker implant</intervention_name>
    <description>Patient will be in the electrophysiology laboratory. The doctor will freeze the groin area and a medication may be given to help the patient relax. A catheter will be inserted into the groin up to the heart and the heart's electrical system will be recorded.</description>
    <arm_group_label>EP-based approach/pacemaker implant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcutaneous cardiac monitor</intervention_name>
    <description>Transcutaneous cardiac patches will allow continuous electrocardiographic monitoring for a 30-day period. For the first randomized patients at the Montreal Heart Institute, Icentia was used and then was changed to a m-Health® device which allows continuous cardiac monitoring. The PocketECG from m-Health® is attached to 3 electrodes on the chest and contains a SIM card that transmits to a server located in Burlington, Ontario .The COME-TAVI coordinating center and the associated site will be informed rapidly of any events that occur . These events include:&#xD;
Ventricular fibrillation; Sustained ventricular tachycardia Any RR interval &gt;5 sec; Third-degree AV block or Mobitz 2 AV block;</description>
    <arm_group_label>Compared transcutaneous cardiac monitor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Informed consent to participate&#xD;
&#xD;
          -  Persistent new-onset LBBB after TAVI implantation (i.e. present at day 2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior pacemaker or implantable cardioverter-defibrillator&#xD;
&#xD;
          -  Pre-existing right bundle branch block (RBBB) or LBBB (i.e., prior to TAVI)&#xD;
&#xD;
          -  Class I or IIA indication for PPM implantation according to management guidelines&#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>Léna Rivard, MD, MSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montreal Heart Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Léna Rivard, MD, MSc</last_name>
    <phone>514-376-3330</phone>
    <phone_ext>2120</phone_ext>
    <email>lena.rivard@umontreal.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Caroline Girard, EP Prof.</last_name>
    <phone>514-376-3330</phone>
    <phone_ext>2905</phone_ext>
    <email>caroline.girard@icm-mhi.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Faculty of Medicine</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T1C8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>lena Rivard, MD, MSc</last_name>
      <phone>514-376-3330</phone>
      <phone_ext>2120</phone_ext>
      <email>lena.rivard@umontreal.ca</email>
    </contact>
    <contact_backup>
      <last_name>Caroline Girard</last_name>
      <phone>514-376-3330</phone>
      <phone_ext>4058</phone_ext>
      <email>caroline.girard@icm-mhi.org</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>May 6, 2016</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>August 25, 2022</last_update_submitted>
  <last_update_submitted_qc>August 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
    <mesh_term>Bundle-Branch Block</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/NCT03303612
org study id: ICM#2015-1949
nct id: NCT03303612
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary hypothesis of the proposed study is that an electrophysiology-based algorithmic
      approach is superior to standard clinical follow-up with 30-day monitoring in reducing the
      combined endpoint of syncope, hospitalization, and death in patients in patients with new of
      left bundle branch block following transcatheter aortic valve implantation (TAVI).
The study population consists of pacemaker-free patients that are 18 years or older
      undergoing a TAVI with new onset left bundle branch block. Patient consent is required.

      Patients meeting the inclusion criteria will be randomized in a 1:1 ratio to one of the
      following two groups:

      Group 1: electrophysiology-based algorithmic approach

      Group 2: standard clinical follow-up with transcutaneous cardiac monitoring.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients with cardiovascular hospitalization, and/or syncope, and/or death after TAVI.
time frame: 12 months
description: This is the number of participants who experienced cardiovascular hospitalizations, and/or syncope, and/or death after TAVI.
measure: Number of participants with cardiovascular hospitalizations.
time frame: 12 months
description: This is the number of participants who were hospitalized for cardiovascular reasons within one-year post-TAVI.
measure: Number of participants with hospitalisations (Total)
time frame: 12 months
description: This is the number of participants who were hospitalized one-year post-TAVI.
measure: Number of participants with emergency visits.
time frame: 12 months
description: This is the number of participants who had emergency visits after TAVI.
measure: Number of participants experiencing syncope
time frame: 12 months
description: This is the number of participants who experienced syncope after TAVI.
measure: Cost-effectiveness of EP-guided procedure compared to cardiac monitoring [incremental cost effectiveness ratio (ICER)].
time frame: 12 months
description: This is the incremental cost effectiveness ratio (ICER) for one strategy compared to the other.
measure: Number of procedural complications in the group of EP-guided procedure compared to the group of cardiac monitoring.
time frame: 30 days
description: This is the number of procedural complications in the group of EP-guided approach compared to cardiac monitoring within 30 days.
measure: Number of atrio-ventricular blocks in the group of EP-guided procedure compared to the group of transcutaneous cardiac monitoring.
time frame: 12 months
description: This is the number of atrio-ventricular blocks in the EP-guided procedure group compared to the transcutaneous cardiac monitoring group within 12 months of TAVI
arm group label: EP-based approach/pacemaker implant
arm group type: Other
description: Subjects will undergo an EP study prior to hospital discharge and will receive a pacemaker implantation if the HV interval is ≥65 msec.
In the case where the electrical slowdown is not confirmed by the electrophysiological study, the participant will not have a pacemaker implantation.
arm group label: Compared transcutaneous cardiac monitor
arm group type: Other
description: Subjects will undergo a minimum of 72 hour ECG monitoring in hospital and receive transcutaneous monitoring prior to hospital discharge for a duration of 30 days.
intervention type: Device
intervention name: Pacemaker implant
description: Patient will be in the electrophysiology laboratory. The doctor will freeze the groin area and a medication may be given to help the patient relax. A catheter will be inserted into the groin up to the heart and the heart's electrical system will be recorded.
arm group label: EP-based approach/pacemaker implant
intervention type: Device
intervention name: Transcutaneous cardiac monitor
description: Transcutaneous cardiac patches will allow continuous electrocardiographic monitoring for a 30-day period. For the first randomized patients at the Montreal Heart Institute, Icentia was used and then was changed to a m-Health® device which allows continuous cardiac monitoring. The PocketECG from m-Health® is attached to 3 electrodes on the chest and contains a SIM card that transmits to a server located in Burlington, Ontario .The COME-TAVI coordinating center and the associated site will be informed rapidly of any events that occur . These events include:
Ventricular fibrillation; Sustained ventricular tachycardia Any RR interval >5 sec; Third-degree AV block or Mobitz 2 AV block;
arm group label: Compared transcutaneous cardiac monitor
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Léna Rivard, MD, MSC
role: Principal Investigator
affiliation: Montreal Heart Institute
last name: Léna Rivard, MD, MSc
phone: 514-376-3330
phone ext: 2120
email: lena.rivard@umontreal.ca
last name: Caroline Girard, EP Prof.
phone: 514-376-3330
phone ext: 2905
email: caroline.girard@icm-mhi.org
facility: 
status: Recruiting
contact: 
contact backup: 
country: Canada
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
mesh term: Bundle-Branch Block
sharing ipd: No