<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/NCT04452149</url>
  </required_header>
  <id_info>
    <org_study_id>ALLEVIATE-HF</org_study_id>
    <nct_id>NCT04452149</nct_id>
  </id_info>
  <brief_title>Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure</brief_title>
  <acronym>ALLEVIATE-HF</acronym>
  <official_title>Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure</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>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The ALLEVIATE-HF study is a prospective, randomized, controlled, blinded, multi-site,&#xD;
      interventional, investigational device exemption (IDE) pivotal study. The purpose of the&#xD;
      study is to demonstrate the safety and efficacy of a patient management pathway that utilizes&#xD;
      an integrated device diagnostic-based risk stratification algorithm to guide patient care in&#xD;
      subjects with NYHA class II and III heart failure, and to demonstrate the safety of the&#xD;
      Reveal LINQ™ system and procedure in the study population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will utilize the market released Reveal LINQ™ Insertable Cardiac Monitor with an&#xD;
      investigational ALLEVIATE-HF RAMware download. The study will enroll up to 700 subjects at up&#xD;
      to 60 sites in the US. Subjects will be followed until the last enrolled subject is followed&#xD;
      for 7 months or until the end of the study, whichever occurs first, or until time of study&#xD;
      exit or death as applicable, but no longer than 36 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 3, 2020</start_date>
  <completion_date type="Anticipated">November 2024</completion_date>
  <primary_completion_date type="Anticipated">November 2024</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>
    <intervention_model_description>Following Reveal LINQ™ device insertion, subjects will be randomly allocated in a blinded fashion in a 1:1 ratio to either the observation arm or the intervention arm. Subjects in the observation arm will start with an observational period of 13 months and then transition to the intervention arm for the remainder of their participation in the study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Study site personnel and subjects will remain blinded to the subject's randomization assignment until the 13-month timepoint at which point the subjects will be in the intervention arm for the remainder of their participation regardless of original allocation, or until the time of investigator and/or subject contact in relation to a &quot;high&quot; risk status in an intervention arm subject.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Safety of patient management pathway - Proportion of medication interventions with associated medication intervention related serious adverse events</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>The proportion of medication interventions with one or more associated medication intervention related SAEs will be evaluated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy of patient management pathway - Hierarchical composite of Cardiovascular death, HF events, change in Kansas City Cardiomyopathy Questionnaire and change in six-minute walk test distance</measure>
    <time_frame>Follow-up duration at endpoint analysis ranges from a minimum of 7 to a maximum of 13 months</time_frame>
    <description>Treatment and Control groups will be compared using the Finkelstein-Schoenfeld method, including subjects with at least one &quot;high&quot; heart failure risk status.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety of Reveal LINQ™ system and procedure - Percentage of subjects experiencing system or procedure related serious adverse events</measure>
    <time_frame>Up to 6 months post Reveal LINQ™ device insertion attempt</time_frame>
    <description>Freedom from Reveal LINQ™ system and procedure related serious adverse events at 6 months will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of patient management pathway - Hierarchical composite of Cardiovascular death, HF events, change in Kansas City Cardiomyopathy Questionnaire, change in six-minute walk test distance, and change in device-measured activity and night heart rate</measure>
    <time_frame>Follow-up duration at endpoint analysis ranges from a minimum of 7 to a maximum of 13 months</time_frame>
    <description>Treatment and Control groups will be compared using the Finkelstein-Schoenfeld method, including subjects with at least one &quot;high&quot; heart failure risk status.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">700</enrollment>
  <condition>Heart Failure NYHA Class II</condition>
  <condition>Heart Failure NYHA Class III</condition>
  <arm_group>
    <arm_group_label>Observation Arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will receive a Reveal LINQ™ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download, and will be managed per standard of care for heart failure management without visibility to the heart failure sensor data. Subjects will transition to the intervention arm after 13 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive a Reveal LINQ™ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download, and will be managed using an integrated device diagnostic-based risk stratification algorithm combined with a clinical medication plan.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download</intervention_name>
    <description>Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download.</description>
    <arm_group_label>Intervention Arm</arm_group_label>
    <arm_group_label>Observation Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medication intervention</intervention_name>
    <description>Risk status guided medication intervention.</description>
    <arm_group_label>Intervention Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient has NYHA Class II or III heart failure per most recent assessment,&#xD;
             irrespective of left ventricular ejection fraction (LVEF)&#xD;
&#xD;
          -  Patient has documented recent history of symptomatic heart failure, defined as meeting&#xD;
             any one of the following three criteria: 1. Hospital admission with primary diagnosis&#xD;
             of HF within the last 12 months, OR 2. Intravenous HF therapy (e.g. IV&#xD;
             diuretics/vasodilators) or ultrafiltration within the last 6 months, OR 3. Patient had&#xD;
             the following BNP/NT-proBNP within the last 3 months: If LVEF ≥ 50%, then BNP&gt; 150&#xD;
             pg/ml or NT-proBNP &gt; 450 pg/ml OR If LVEF is &lt;50%, then BNP&gt; 300 pg/ml or NT-proBNP &gt;&#xD;
             900 pg/ml&#xD;
&#xD;
          -  Patient is willing and able to comply with the protocol, including LINQ ICM insertion,&#xD;
             CareLink transmissions (including adequate connectivity), study visits and remote care&#xD;
             directions.&#xD;
&#xD;
          -  Patient is 18 years of age or older.&#xD;
&#xD;
          -  Patient has a life expectancy of 12 months or more.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is currently implanted with a cardiovascular implantable electronic device&#xD;
             (CIED) (e.g. ICM, pacemaker, ICD, CRT-D or CRT-P device) or hemodynamic monitor.&#xD;
&#xD;
          -  Patient is receiving temporary or permanent mechanical circulatory support.&#xD;
&#xD;
          -  Patient had MI or PCI/CABG within past 90 days.&#xD;
&#xD;
          -  Patient has had a heart transplant, or is currently on heart transplant list.&#xD;
&#xD;
          -  Patient has severe valve stenosis on echocardiogram.&#xD;
&#xD;
          -  Patient has primary pulmonary hypertension (pre-capillary, WHO group 1,3,4,5).&#xD;
&#xD;
          -  Patient is on chronic intravenous inotropic drug therapy (e.g. dobutamine, milrinone).&#xD;
&#xD;
          -  Patient has severe renal impairment (eGFR &lt;30 mL/min).&#xD;
&#xD;
          -  Patient has systolic blood pressure of &lt; 90 mmHg at the time of enrollment.&#xD;
&#xD;
          -  Patient is on chronic renal dialysis.&#xD;
&#xD;
          -  Patient is unable to undergo one round of PRN medication intervention (i.e. 4 days of&#xD;
             increased diuretics dose).&#xD;
&#xD;
          -  Patient has liver disease, defined as AST/ALT &gt;5x normal, or bilirubin &gt;2x normal.&#xD;
&#xD;
          -  Patient has serum albumin &lt; 3 g/dL.&#xD;
&#xD;
          -  Patient has hypertrophic obstructive cardiomyopathy, constrictive pericarditis or&#xD;
             amyloidosis.&#xD;
&#xD;
          -  Patient has complex adult congenital heart disease.&#xD;
&#xD;
          -  Patient has active cancer involving chemotherapy and/or radiation therapy.&#xD;
&#xD;
          -  Patient weighs more than 500 pounds.&#xD;
&#xD;
          -  Patient is pregnant or breastfeeding (all females of child-bearing potential must have&#xD;
             a negative pregnancy test within 1 week of enrollment).&#xD;
&#xD;
          -  Patient is enrolled in another interventional study.&#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>Javed Butler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Mississippi Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aimee Laechelt</last_name>
    <phone>(+1-763) 526-2730</phone>
    <email>aimee.a.laechelt@medtronic.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cardiovascular Associates of Mesa</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85282</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ambrose Panico, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Arrhythmia Research Group</name>
      <address>
        <city>Jonesboro</city>
        <state>Arkansas</state>
        <zip>72410</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Devi Nair, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Heritage Healthcare</name>
      <address>
        <city>Mission Viejo</city>
        <state>California</state>
        <zip>92691</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Cardiology Associates Medical Group</name>
      <address>
        <city>Oxnard</city>
        <state>California</state>
        <zip>93030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jonathan Dukes, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Saint Joseph's Medical Center</name>
      <address>
        <city>Stockton</city>
        <state>California</state>
        <zip>95204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cyrus Buhari, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>South Denver Cardiology Associates</name>
      <address>
        <city>Littleton</city>
        <state>Colorado</state>
        <zip>80120</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ira Dauber, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>FWD Clinical Research LLC</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Cammarata, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Bay Area Cardiology Associates PA</name>
      <address>
        <city>Brandon</city>
        <state>Florida</state>
        <zip>33511</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephen Mester, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Florida Heart Center</name>
      <address>
        <city>Fort Pierce</city>
        <state>Florida</state>
        <zip>34950</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Prasad Chalasani, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Baptist Health</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ruple Galani, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>First Coast Cardiovascular Institute PA</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sumant Lamba, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Citrus Cardiology Consultants PA</name>
      <address>
        <city>Leesburg</city>
        <state>Florida</state>
        <zip>34748</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hector Garcia, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Baptist Hospital</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32501</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sumit Verma, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Northside Hospital</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33709</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert Sanchez, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tallahassee Research Institute</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32308</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gian-Carlo Giove, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Health University Medical Center</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31404</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Newton, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>NorthShore University Health System</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mark Metzl, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Carle Foundation Hospital</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Parkview Health</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46845</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick Gregory, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ascension Medical Group - Saint Vincent</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sunit-Preet Chaudhry, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Iowa Heart Center</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50266</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Madhu Reddy, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Saint Elizabeth Healthcare</name>
      <address>
        <city>Edgewood</city>
        <state>Kentucky</state>
        <zip>41017</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hareeprasad Vongooru, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Baptist Healthcare System</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40207</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Steven Heatherly, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Norton Healthcare</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40217</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Srikanth Seethala, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Advanced Cardiovascular Specialists</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>North Memorial Health Heart &amp; Vascular Center</name>
      <address>
        <city>Robbinsdale</city>
        <state>Minnesota</state>
        <zip>55422</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chike Obi, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert Craig Long, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cardiology Associates of North Mississippi</name>
      <address>
        <city>Tupelo</city>
        <state>Mississippi</state>
        <zip>38801</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Barry Bertolet, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Missouri Cardiovascular Specialists</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>CHI Health Nebraska Heart</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68526</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>CHI Health Creighton University Medical Center - Bergan Mercy</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68124</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Selma Mohammed, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lourdes Cardiology Services</name>
      <address>
        <city>Voorhees</city>
        <state>New Jersey</state>
        <zip>08043</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Darius Sholevar, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>New Mexico Heart Institute PA</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eddie Brown, D.O.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>New York-Presbyterian Brooklyn Methodist Hospital</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bharath Reddy, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>NYU Langone Hospital Long Island</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Seth Bender, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Columbia University Irving Medical Center/NYPH</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kelly Axsom, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hudson Valley Heart Center</name>
      <address>
        <city>Poughkeepsie</city>
        <state>New York</state>
        <zip>12601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>James Lyons, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Saint Francis Hospital</name>
      <address>
        <city>Roslyn</city>
        <state>New York</state>
        <zip>11576</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rita Jermyn, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Stony Brook University Hospital</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hal Skopicki, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cone Health</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Novant Health New Hanover Regional Medical Center</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John Rommel, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Lindner Research Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ankit Bhatia, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Mount Carmel East</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laura Gravelin, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>OhioHealth Research and Innovation Institute (OHRI)</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43214</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anup Basuray, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Doylestown Health Cardiology a division of Doylestown Health Physicians</name>
      <address>
        <city>Doylestown</city>
        <state>Pennsylvania</state>
        <zip>18901</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Renee Sangrigoli, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cardiology Consultants of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthew Goldstein, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gregory Jackson, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Prisma Health Midlands</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>W. Robert Mazzei, M.D.</last_name>
    </contact>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Frank McGrew, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Tennessee Methodist Physicians</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Isaac Rhea, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medical City Fort Worth</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amir Malik, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tyler Cardiovascular Consultants</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raul Torres, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Virginia Medical Center</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Sentara Norfolk General Hospital</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Erich Kiehl, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center Cherry Hill</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John Mignone, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Medical Center (Tacoma WA)</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Zhang, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Charleston Area Medical Center (CAMC) Memorial Hospital</name>
      <address>
        <city>Charleston</city>
        <state>West Virginia</state>
        <zip>25304</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elie Gharib, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>West Virginia University</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>George Sokos, M.D.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>September 14, 2023</last_update_submitted>
  <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Heart Failure</keyword>
  <keyword>Insertable Cardiac Monitor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</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/NCT04452149
org study id: ALLEVIATE-HF
nct id: NCT04452149
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
The ALLEVIATE-HF study is a prospective, randomized, controlled, blinded, multi-site,
      interventional, investigational device exemption (IDE) pivotal study. The purpose of the
      study is to demonstrate the safety and efficacy of a patient management pathway that utilizes
      an integrated device diagnostic-based risk stratification algorithm to guide patient care in
      subjects with NYHA class II and III heart failure, and to demonstrate the safety of the
      Reveal LINQ™ system and procedure in the study population.
The study will utilize the market released Reveal LINQ™ Insertable Cardiac Monitor with an
      investigational ALLEVIATE-HF RAMware download. The study will enroll up to 700 subjects at up
      to 60 sites in the US. Subjects will be followed until the last enrolled subject is followed
      for 7 months or until the end of the study, whichever occurs first, or until time of study
      exit or death as applicable, but no longer than 36 months.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Following Reveal LINQ™ device insertion, subjects will be randomly allocated in a blinded fashion in a 1:1 ratio to either the observation arm or the intervention arm. Subjects in the observation arm will start with an observational period of 13 months and then transition to the intervention arm for the remainder of their participation in the study.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Study site personnel and subjects will remain blinded to the subject's randomization assignment until the 13-month timepoint at which point the subjects will be in the intervention arm for the remainder of their participation regardless of original allocation, or until the time of investigator and/or subject contact in relation to a "high" risk status in an intervention arm subject.
measure: Safety of patient management pathway - Proportion of medication interventions with associated medication intervention related serious adverse events
time frame: Up to 3 years
description: The proportion of medication interventions with one or more associated medication intervention related SAEs will be evaluated.
measure: Efficacy of patient management pathway - Hierarchical composite of Cardiovascular death, HF events, change in Kansas City Cardiomyopathy Questionnaire and change in six-minute walk test distance
time frame: Follow-up duration at endpoint analysis ranges from a minimum of 7 to a maximum of 13 months
description: Treatment and Control groups will be compared using the Finkelstein-Schoenfeld method, including subjects with at least one "high" heart failure risk status.
measure: Safety of Reveal LINQ™ system and procedure - Percentage of subjects experiencing system or procedure related serious adverse events
time frame: Up to 6 months post Reveal LINQ™ device insertion attempt
description: Freedom from Reveal LINQ™ system and procedure related serious adverse events at 6 months will be evaluated.
measure: Efficacy of patient management pathway - Hierarchical composite of Cardiovascular death, HF events, change in Kansas City Cardiomyopathy Questionnaire, change in six-minute walk test distance, and change in device-measured activity and night heart rate
time frame: Follow-up duration at endpoint analysis ranges from a minimum of 7 to a maximum of 13 months
description: Treatment and Control groups will be compared using the Finkelstein-Schoenfeld method, including subjects with at least one "high" heart failure risk status.
arm group label: Observation Arm
arm group type: Placebo Comparator
description: Subjects will receive a Reveal LINQ™ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download, and will be managed per standard of care for heart failure management without visibility to the heart failure sensor data. Subjects will transition to the intervention arm after 13 months.
arm group label: Intervention Arm
arm group type: Experimental
description: Subjects will receive a Reveal LINQ™ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download, and will be managed using an integrated device diagnostic-based risk stratification algorithm combined with a clinical medication plan.
intervention type: Device
intervention name: Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download
description: Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download.
arm group label: Intervention Arm
arm group label: Observation Arm
intervention type: Other
intervention name: Medication intervention
description: Risk status guided medication intervention.
arm group label: Intervention Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Javed Butler, MD
role: Principal Investigator
affiliation: University of Mississippi Medical Center
last name: Aimee Laechelt
phone: (+1-763) 526-2730
email: aimee.a.laechelt@medtronic.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Suspended
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No