<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/NCT04421040</url>
  </required_header>
  <id_info>
    <org_study_id>17-006298</org_study_id>
    <nct_id>NCT04421040</nct_id>
  </id_info>
  <brief_title>Long-term Monitoring of Patients With Cardiac Amyloidosis With Implantable Event Monitors</brief_title>
  <official_title>Long-term Monitoring of Patients With Cardiac Amyloidosis With Implantable Event Monitors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Researchers are gathering information to see if using an FDA approved implantable device can&#xD;
      help with monitoring of your heart arrhythmias.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 7, 2020</start_date>
  <completion_date type="Anticipated">December 2023</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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>50 patients with TTR-wt cardiac amyloidosis will be monitored with an implantable loop recorder to determine frequency of atrial and ventricular arrhythmias. After 6 months the device will be explanted unless required for further clinical monitoring.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sudden death</measure>
    <time_frame>6 months</time_frame>
    <description>Total number of patients with sudden death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Atrial arrhythmias</measure>
    <time_frame>6 months</time_frame>
    <description>Frequency of atrial arrhythmias</description>
  </primary_outcome>
  <primary_outcome>
    <measure>High grade AV block</measure>
    <time_frame>6 months</time_frame>
    <description>Total number of patients with high grade AV block</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sinus node dysfunction</measure>
    <time_frame>6 months</time_frame>
    <description>Total number of patients with sinus node dysfunction</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>TTR Cardiac Amyloidosis</condition>
  <arm_group>
    <arm_group_label>Biomonitor 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placement of Biotronic 3 Device for a 6 month period. After the 6 month monitoring period, the patient will have the Biotronic 3 device removed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biotronic 3 implant of device</intervention_name>
    <description>The Biotronic 3 device will be implanted by the research team physician.</description>
    <arm_group_label>Biomonitor 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biotonic 3 explant of device</intervention_name>
    <description>The Biotronic 3 device will be removed from the patient by the research team physician.</description>
    <arm_group_label>Biomonitor 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cardiac biopsy or technetium pyrophosphate scintigraphy confirmed patients&#xD;
&#xD;
          -  Stage I, II, and early and late stage III in numbers as described , irrespective of EF&#xD;
             or NYHA functional class&#xD;
&#xD;
          -  Patients aged 18 -85, both genders and of all races and ethnicities.&#xD;
&#xD;
          -  Patients must be competent to give informed consent.&#xD;
&#xD;
          -  Patients must be able to have the Biomonitor 3 implanted.&#xD;
&#xD;
          -  Amyloid stage I-III patients with existing implantable cardiac devices such as&#xD;
             pacemakers or defibrillators&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant coronary artery disease &gt; 75% luminal stenosis in at least 1 epicardial&#xD;
             vessel (by cardiac catheterization or coronary computed tomography), or history of&#xD;
             myocardial infarction or coronary revascularization.&#xD;
&#xD;
          -  Congenital heart disease.&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Patients whose heart failure is felt to be secondary to primary valvular disease&#xD;
             (&gt;moderate/severe mitral regurgitation), uncorrected thyroid disease, obstructive or&#xD;
             hypertrophic cardiomyopathy, pericardial disease or a systemic illness.&#xD;
&#xD;
          -  Absolute contraindications to cardiac MRI (such as renal failure with GFR&lt;30%).&#xD;
&#xD;
          -  Unwilling or unable to provide informed consent.&#xD;
&#xD;
          -  Patients with other life threatening diseases that would likely decrease their life&#xD;
             expectancy over the next four years.&#xD;
&#xD;
          -  Patients who are post cardiac transplant.&#xD;
&#xD;
          -  Difficulty to attend the follow-up schedule due to a history of medical noncompliance,&#xD;
             difficulty, or unwillingness to return to the study center for follow up.&#xD;
&#xD;
          -  Evidence of ongoing bacteremia or sepsis preventing implantation of a device&#xD;
&#xD;
          -  Unwilling or able to have the Biomonitor 3 interrogated&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Grace Lin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melissa Rott, RN</last_name>
      <phone>507-266-2504</phone>
      <email>Rott.Melissa@mayo.edu</email>
    </contact>
    <investigator>
      <last_name>Grace Lin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>May 31, 2023</last_update_submitted>
  <last_update_submitted_qc>May 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Grace Lin</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amyloidosis</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/NCT04421040
org study id: 17-006298
nct id: NCT04421040
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
Researchers are gathering information to see if using an FDA approved implantable device can
      help with monitoring of your heart arrhythmias.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: 50 patients with TTR-wt cardiac amyloidosis will be monitored with an implantable loop recorder to determine frequency of atrial and ventricular arrhythmias. After 6 months the device will be explanted unless required for further clinical monitoring.
primary purpose: Prevention
masking: None (Open Label)
measure: Sudden death
time frame: 6 months
description: Total number of patients with sudden death
measure: Atrial arrhythmias
time frame: 6 months
description: Frequency of atrial arrhythmias
measure: High grade AV block
time frame: 6 months
description: Total number of patients with high grade AV block
measure: Sinus node dysfunction
time frame: 6 months
description: Total number of patients with sinus node dysfunction
arm group label: Biomonitor 3
arm group type: Experimental
description: Placement of Biotronic 3 Device for a 6 month period. After the 6 month monitoring period, the patient will have the Biotronic 3 device removed.
intervention type: Device
intervention name: Biotronic 3 implant of device
description: The Biotronic 3 device will be implanted by the research team physician.
arm group label: Biomonitor 3
intervention type: Device
intervention name: Biotonic 3 explant of device
description: The Biotronic 3 device will be removed from the patient by the research team physician.
arm group label: Biomonitor 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Grace Lin, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Grace Lin
investigator title: Principal Investigator
mesh term: Amyloidosis
sharing ipd: No