<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/NCT04506684</url>
  </required_header>
  <id_info>
    <org_study_id>MDT20022</org_study_id>
    <nct_id>NCT04506684</nct_id>
  </id_info>
  <brief_title>Reveal LINQ Respiration Clinical Study</brief_title>
  <official_title>Reveal LINQ Respiration Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Cardiac Rhythm and Heart Failure</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Cardiac Rhythm and Heart Failure</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The LINQ™ Respiration study will collect and characterize Reveal LINQ™ derived respiration&#xD;
      data from patients undergoing a simulated 24-hour time period while being monitored with&#xD;
      capnography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Reveal LINQ™ Respiration study is a Non-Significant Risk IDE, observational,&#xD;
      non-randomized, multi-center, clinical study. The study is expected to be conducted at up to&#xD;
      5 centers in the United States and up to 100 subjects will be enrolled, with no more than 25&#xD;
      subjects enrolled per site. In addition, a minimum of 30% of all enrolled subjects will have&#xD;
      a history of heart failure.&#xD;
&#xD;
      All enrolled subjects will either have the investigational LINQ HF or ALLEVIATE-HF RAMware&#xD;
      downloaded onto their implanted Reveal LINQ device, Holter monitor and capnography monitor&#xD;
      applied and undergo a series of activity and breathing maneuvers. The expected duration of&#xD;
      subject participation in the study (from start of study procedures to study exit) is&#xD;
      approximately 1.5 hours. The expected total study duration (from time of first enrollment to&#xD;
      the exit of last enrolled subject) is approximately 3 months.&#xD;
&#xD;
      All Adverse events will be collected throughout the study duration of a subject's&#xD;
      participation in the study, beginning at the time of informed consent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 25, 2020</start_date>
  <completion_date type="Actual">July 31, 2021</completion_date>
  <primary_completion_date type="Actual">July 31, 2021</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>Demonstrating an agreement between LINQ and capnography derived respiratory rate</measure>
    <time_frame>6 months</time_frame>
    <description>The primary objective is to demonstrate an acceptable agreement between Reveal LINQ™ derived respiratory rate and capnography waveform-derived respiratory rate.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Characterizing the agreement between LINQ and capnography derived respiratory rate</measure>
    <time_frame>6 months</time_frame>
    <description>The secondary objective is to characterize the agreement between Reveal LINQ™ derived respiratory rate with capnography waveform-derived respiratory rate utilizing all paired measurements captured during the study protocol.</description>
  </secondary_outcome>
  <enrollment type="Actual">79</enrollment>
  <condition>Respiratory Rate</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Investigational RAMware downloaded onto Reveal LINQ device</intervention_name>
    <description>The study is utilizing an investigational RAMware, either LINQ HF or ALLEVIATE-HF, that will be downloaded onto the subject's market-released Medtronic Reveal LINQ ICM. The investigational RAMware enables the hardware to record and store additional sensor data from which a respiratory rate will be derived.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The target population for the LINQ Respiration study will include subjects who are ≥ 55&#xD;
        years old and implanted with a Reveal LINQ device for ≥60 days and no longer than 3 years.&#xD;
        In addition, a minimum of 30% of all enrolled subjects will have a documented history of&#xD;
        heart failure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is ≥ 55 years old&#xD;
&#xD;
          -  Patient (or patient's legally authorized representative) is willing and able to&#xD;
             provide written informed consent&#xD;
&#xD;
          -  Patient is willing and able to comply with the study procedures&#xD;
&#xD;
          -  Patient has an active Medtronic Reveal LINQ device that has been implanted for ≥ 60&#xD;
             days and no more than 3 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has an existing condition that necessitates the use of supplemental oxygen&#xD;
&#xD;
          -  Patient has an active acute respiratory infection or a respiratory disorder that may&#xD;
             affect ability to perform respiratory maneuvers&#xD;
&#xD;
          -  Patient has NYHA Class IV heart failure per most recent assessment&#xD;
&#xD;
          -  Any concomitant condition that might endanger the patient through participation in the&#xD;
             study or interfere with study procedures, as assessed by the investigator&#xD;
&#xD;
          -  Patient is enrolled in another study that could confound the results of this study&#xD;
&#xD;
          -  Patient has an existing implantation of Medtronic IPG, ICD, CRT-D or CRT-P device&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Cardiac Arrhythmia Service</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CentraCare Heart &amp; Vascular Center</name>
      <address>
        <city>Saint Cloud</city>
        <state>Minnesota</state>
        <zip>56303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma Heart Hospital Research Foundation</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Stern Cardiovascular Foundation</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>October 14, 2022</last_update_submitted>
  <last_update_submitted_qc>October 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Reveal LINQ device</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share IPD</ipd_description>
  </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/NCT04506684
org study id: MDT20022
nct id: NCT04506684
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The LINQ™ Respiration study will collect and characterize Reveal LINQ™ derived respiration
      data from patients undergoing a simulated 24-hour time period while being monitored with
      capnography.
The Reveal LINQ™ Respiration study is a Non-Significant Risk IDE, observational,
      non-randomized, multi-center, clinical study. The study is expected to be conducted at up to
      5 centers in the United States and up to 100 subjects will be enrolled, with no more than 25
      subjects enrolled per site. In addition, a minimum of 30% of all enrolled subjects will have
      a history of heart failure.

      All enrolled subjects will either have the investigational LINQ HF or ALLEVIATE-HF RAMware
      downloaded onto their implanted Reveal LINQ device, Holter monitor and capnography monitor
      applied and undergo a series of activity and breathing maneuvers. The expected duration of
      subject participation in the study (from start of study procedures to study exit) is
      approximately 1.5 hours. The expected total study duration (from time of first enrollment to
      the exit of last enrolled subject) is approximately 3 months.

      All Adverse events will be collected throughout the study duration of a subject's
      participation in the study, beginning at the time of informed consent.
observational model: Cohort
time perspective: Prospective
measure: Demonstrating an agreement between LINQ and capnography derived respiratory rate
time frame: 6 months
description: The primary objective is to demonstrate an acceptable agreement between Reveal LINQ™ derived respiratory rate and capnography waveform-derived respiratory rate.
measure: Characterizing the agreement between LINQ and capnography derived respiratory rate
time frame: 6 months
description: The secondary objective is to characterize the agreement between Reveal LINQ™ derived respiratory rate with capnography waveform-derived respiratory rate utilizing all paired measurements captured during the study protocol.
intervention type: Device
intervention name: Investigational RAMware downloaded onto Reveal LINQ device
description: The study is utilizing an investigational RAMware, either LINQ HF or ALLEVIATE-HF, that will be downloaded onto the subject's market-released Medtronic Reveal LINQ ICM. The investigational RAMware enables the hardware to record and store additional sensor data from which a respiratory rate will be derived.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
ipd description: No plan to share IPD