<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/NCT03016754</url>
  </required_header>
  <id_info>
    <org_study_id>90D0109</org_study_id>
    <nct_id>NCT03016754</nct_id>
  </id_info>
  <brief_title>Heart Failure Optimization Study</brief_title>
  <acronym>HF-Opt</acronym>
  <official_title>Heart Failure Optimization Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zoll Medical Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zoll Medical Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed as a multi-center prospective observational study of newly diagnosed&#xD;
      Heart Failure (HF) patients to test the hypothesis that additional Ejection Fraction (EF)&#xD;
      recovery occurs between 90 and 180 days as Guideline Directed Medical Therapy (GDMT) is&#xD;
      achieved. Although the study doesn't start until day 90, all eligible, consenting patients&#xD;
      will be entered into a registry at the start of wearable cardioverter defibrillator (WCD)&#xD;
      use. The pre-study registry will allow us to collect early (90 day) outcomes and data in&#xD;
      those patients who are likely to be eligible for the study at day 90, or are eligible, but&#xD;
      refuse the study at day 90.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be conducted at thirty to sixty sites, initially in US and Europe. It will be&#xD;
      used to observe the rate of recovery of ventricular function (EF&gt;35%) between 90 and 180 days&#xD;
      in newly diagnosed HF patients who were prescribed the WCD ≤ 10 days post-discharge after&#xD;
      hospitalization for a primary reason of new onset HF (≤30 days since first HF&#xD;
      hospitalization), with ischemic or non-ischemic cardiomyopathy, and have already used a WCD&#xD;
      for 90 ± 14 days. For the first 90 days of WCD use, patients will be enrolled in a pre-study&#xD;
      registry. The FDA-approved WCD will be prescribed for up to 6 months of use after hospital&#xD;
      discharge, with the option for longer use under physician discretion. Approximately 870&#xD;
      subjects will enroll into the pre-study registry and 750 subjects into the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">June 1, 2022</completion_date>
  <primary_completion_date type="Actual">June 1, 2022</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>Do not require ICD implant</measure>
    <time_frame>180 days</time_frame>
    <description>Patient improved (EF &gt;35%), SCD risk deemed to be negligible. These patients will end WCD use and not receive an ICD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Continue WCD use</measure>
    <time_frame>180 days</time_frame>
    <description>Patient improved EF from start of WCD use (a positive change of at least 5 percentage points in EF), or has a borderline EF of 30-35%, but still has continued SCD risk (EF ≤ 35%). These patients are expected to continue to use the WCD for an additional 3 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Meet GDMT</measure>
    <time_frame>180 days</time_frame>
    <description>Patient not improved from start of WCD use (no change or worsening of EF), EF&lt;30% and has continued high SCD risk. These patients will either continue the WCD for an additional 90 days if not on GDMT, or receive an ICD if already on GDMT.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of other arrhythmias</measure>
    <time_frame>180 days</time_frame>
    <description>Observe the incidence of other arrhythmias during WCD use, such as asystole and supra-ventricular arrhythmias that are recorded by the device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine the number of ICD treatment shocks</measure>
    <time_frame>180 days</time_frame>
    <description>Collect ICD treatment data for those who receive an ICD, and evaluate for appropriateness as assessed by ECG recordings.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy in ventricular arrhythmias</measure>
    <time_frame>180 days</time_frame>
    <description>Observe the effectiveness of the wearable defibrillator worn by this population in treating ventricular arrhythmias. Clinical outcomes data from any defibrillation or cardiac event will be collected, including device data on appropriate arrhythmia detection and shock delivery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality following hospital discharge</measure>
    <time_frame>360 days</time_frame>
    <description>Evaluate the effect of wearable defibrillators on 90,180, 270, and 360-day mortality following discharge in HF patients. Assessment of survival will be made at these time points for those entered into the study. A mortality review will be conducted to group all deaths as cardiac or non-cardiac, and sudden or non-sudden.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost of healthcare utilization</measure>
    <time_frame>360 days</time_frame>
    <description>Assess cost of healthcare utilization (emergency room visits, hospitalizations, doctor visits etc.) on all patients during the period of the study.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Complications from extended use</measure>
    <time_frame>360 days</time_frame>
    <description>The safety objectives will be to compare complications from extended use of the WCD with those of the ICD during the study timeframe.</description>
  </other_outcome>
  <enrollment type="Actual">622</enrollment>
  <condition>Sudden Cardiac Death</condition>
  <condition>Sudden Cardiac Arrest</condition>
  <condition>Heart Failure</condition>
  <condition>Heart Failure Low Output</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Wearable Cardioverter Defibrillator</intervention_name>
    <description>LifeVest Wearable Cardioverter Defibrillator</description>
    <other_name>LifeVest</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        In-Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Part 1&#xD;
&#xD;
          -  Patients (≥18 years old) who were prescribed the WCD ≤ 10 days post-discharge after&#xD;
             hospitalization for a primary reason of new onset HF (≤30 days since first HF&#xD;
             hospitalization), with ischemic or nonischemic cardiomyopathy, and have used the WCD&#xD;
             for no more than 30 days.&#xD;
&#xD;
          -  Patients who had an EF ≤ 35% during index hospitalization (must be last measurement if&#xD;
             performed multiple times).&#xD;
&#xD;
        Part 2&#xD;
&#xD;
          -  Patients (≥18 years old) who were prescribed the WCD ≤ 10 days post-discharge after&#xD;
             hospitalization for a primary reason of new onset HF (≤30 days since first HF&#xD;
             hospitalization), with ischemic or nonischemic cardiomyopathy, and have already used a&#xD;
             WCD for 90 ± 14 days.&#xD;
&#xD;
          -  Patients who had an EF ≤ 35% during index hospitalization (must be last measurement if&#xD;
             performed multiple times). Of note, EF at 90 ± 14 days post-hospitalization does not&#xD;
             need to be low to be included in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 18 years old.&#xD;
&#xD;
          -  Patients who have an active unipolar pacemaker.&#xD;
&#xD;
          -  Patients with a physical or mental condition that could impair their ability to&#xD;
             properly interact with the device.&#xD;
&#xD;
          -  Patients currently participating in another clinical study.&#xD;
&#xD;
          -  Patients with any skin condition that would prevent wearing the device.&#xD;
&#xD;
          -  Patients with an advanced directive prohibiting resuscitation.&#xD;
&#xD;
          -  Patients who are indicated for cardiac resynchronization therapy or have a QRS&#xD;
             duration of ≥135 ms.&#xD;
&#xD;
          -  Patients with recent myocardial infarction or coronary revascularization (since start&#xD;
             of WCD wear; i.e. 0-90 days of WCD wear).&#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>Mike Osz</last_name>
    <role>Study Director</role>
    <affiliation>Director, Clinical Operations</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UAB Division of Cardiovascular Disease</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site</name>
      <address>
        <city>West Hills</city>
        <state>California</state>
        <zip>91307</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Heart Specialists</name>
      <address>
        <city>Fernandina Beach</city>
        <state>Florida</state>
        <zip>32034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Heart Specialists</name>
      <address>
        <city>Jacksonville Beach</city>
        <state>Florida</state>
        <zip>32250</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Heart Specialists</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Cardiovascular Research</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34471</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Physicians Network Alliance</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32825</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33709</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fox Valley Clinical Research Center</name>
      <address>
        <city>Aurora</city>
        <state>Illinois</state>
        <zip>60506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chicago Medical Research, LLC</name>
      <address>
        <city>Hazel Crest</city>
        <state>Illinois</state>
        <zip>60429</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unity Point Health-Methodist</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Research of Northwest Indiana, LLC</name>
      <address>
        <city>Munster</city>
        <state>Indiana</state>
        <zip>46321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beacon Medical Group clinical Research</name>
      <address>
        <city>South Bend</city>
        <state>Indiana</state>
        <zip>26554</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph London</name>
      <address>
        <city>London</city>
        <state>Kentucky</state>
        <zip>40741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Covenant Medical Center, Inc.</name>
      <address>
        <city>Saginaw</city>
        <state>Michigan</state>
        <zip>48602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jackson Heart Clinic</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Luke's Hospital of Kansas City</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SSM Health Heart &amp; Vascular</name>
      <address>
        <city>Lake Saint Louis</city>
        <state>Missouri</state>
        <zip>63367</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Louis Heart and Vascular</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensack Meridian Health</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AtlantiCare Regional Medical Center</name>
      <address>
        <city>Pomona</city>
        <state>New Jersey</state>
        <zip>08240</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Trinity Medical Center</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SJH Cardiology</name>
      <address>
        <city>Liverpool</city>
        <state>New York</state>
        <zip>13088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UNC Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Cardiology Associates</name>
      <address>
        <city>Barberton</city>
        <state>Ohio</state>
        <zip>44203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drexel University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Temple University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guthrie Medical Group, P.C.</name>
      <address>
        <city>Sayre</city>
        <state>Pennsylvania</state>
        <zip>18840</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Heart Specialists</name>
      <address>
        <city>Lancaster</city>
        <state>South Carolina</state>
        <zip>29720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Health</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist University Hospital (MUH) and Methodist OliveBranch (MOB)</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist South (MS) University Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38116</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkway Cardiology</name>
      <address>
        <city>Oak Ridge</city>
        <state>Tennessee</state>
        <zip>37830</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Health Research &amp; Education Institute</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mission Research Insitute</name>
      <address>
        <city>New Braunfels</city>
        <state>Texas</state>
        <zip>78130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Health Center</name>
      <address>
        <city>Waco</city>
        <state>Texas</state>
        <zip>76712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Mary's Medical Center</name>
      <address>
        <city>Huntington</city>
        <state>West Virginia</state>
        <zip>25702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordensklinikum Linz GmbH/Elisabethinen</name>
      <address>
        <city>Linz</city>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universitätsklinik Wien</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Sud Francilien</name>
      <address>
        <city>Corbeil-Essonnes</city>
        <zip>91106</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Grenoble site Nord- Hopital Albert Michallon</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Clermont-Ferrand- Hopital Albert Michallon</name>
      <address>
        <city>Grenoble</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Europeen Georges Pompidou</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Pontchaillou</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Pasteur</name>
      <address>
        <city>Toulouse</city>
        <zip>31076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amper Kliniken AG, Heliios Amper-Klinikum Dachau</name>
      <address>
        <city>Dachau</city>
        <state>Bavaria</state>
        <zip>85221</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik u. Polikllinik Fur Innere Med. II Kardiologie</name>
      <address>
        <city>Regensburg</city>
        <state>Bayern</state>
        <zip>93042</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schwarzwald-Baar Klinik</name>
      <address>
        <city>Villingen-Schwenningen</city>
        <state>Deutschland</state>
        <zip>78052</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elisabeth-Krankenhaus</name>
      <address>
        <city>Essen</city>
        <state>NRW</state>
        <zip>45138</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Augsburg</name>
      <address>
        <city>Augsburg</city>
        <zip>86156</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herz- und Gefäßklinik Bad Neustadt</name>
      <address>
        <city>Bad Neustadt an der Saale</city>
        <zip>97616</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik Barmbek</name>
      <address>
        <city>Barmbek</city>
        <zip>22291</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vinzenz Hospital</name>
      <address>
        <city>Cologne</city>
        <zip>50733</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Duesseldorf</name>
      <address>
        <city>Duesseldorf</city>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UKGM, Standort Giessen</name>
      <address>
        <city>Giessen</city>
        <zip>35392</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Harzklinik Goslar</name>
      <address>
        <city>Goslar</city>
        <zip>38642</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Halle</name>
      <address>
        <city>Halle</city>
        <zip>06120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik Wandsbek</name>
      <address>
        <city>Hamburg</city>
        <zip>22043</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kardiologie, Asklepios Klinik St. Georg</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover</name>
      <address>
        <city>Hannöver</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herzzentrum Leipzig GmbH</name>
      <address>
        <city>Leipzig</city>
        <zip>04289</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Ludenscheid</name>
      <address>
        <city>Ludenscheid</city>
        <zip>58515</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Katholisches Klinikum Lunen</name>
      <address>
        <city>Lunen</city>
        <zip>44534</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Ulm</name>
      <address>
        <city>Ulm</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>France</country>
    <country>Germany</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>June 8, 2022</last_update_submitted>
  <last_update_submitted_qc>June 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sudden cardiac death</keyword>
  <keyword>SCD</keyword>
  <keyword>sudden cardiac arrest</keyword>
  <keyword>SCA</keyword>
  <keyword>heart failure</keyword>
  <keyword>HF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Heart Arrest</mesh_term>
    <mesh_term>Death, Sudden, Cardiac</mesh_term>
    <mesh_term>Death</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>June 27, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03016754
org study id: 90D0109
nct id: NCT03016754
lead sponsor: 
has dmc: No
This study is designed as a multi-center prospective observational study of newly diagnosed
      Heart Failure (HF) patients to test the hypothesis that additional Ejection Fraction (EF)
      recovery occurs between 90 and 180 days as Guideline Directed Medical Therapy (GDMT) is
      achieved. Although the study doesn't start until day 90, all eligible, consenting patients
      will be entered into a registry at the start of wearable cardioverter defibrillator (WCD)
      use. The pre-study registry will allow us to collect early (90 day) outcomes and data in
      those patients who are likely to be eligible for the study at day 90, or are eligible, but
      refuse the study at day 90.
This study will be conducted at thirty to sixty sites, initially in US and Europe. It will be
      used to observe the rate of recovery of ventricular function (EF>35%) between 90 and 180 days
      in newly diagnosed HF patients who were prescribed the WCD ≤ 10 days post-discharge after
      hospitalization for a primary reason of new onset HF (≤30 days since first HF
      hospitalization), with ischemic or non-ischemic cardiomyopathy, and have already used a WCD
      for 90 ± 14 days. For the first 90 days of WCD use, patients will be enrolled in a pre-study
      registry. The FDA-approved WCD will be prescribed for up to 6 months of use after hospital
      discharge, with the option for longer use under physician discretion. Approximately 870
      subjects will enroll into the pre-study registry and 750 subjects into the study.
observational model: Cohort
time perspective: Prospective
measure: Do not require ICD implant
time frame: 180 days
description: Patient improved (EF >35%), SCD risk deemed to be negligible. These patients will end WCD use and not receive an ICD.
measure: Continue WCD use
time frame: 180 days
description: Patient improved EF from start of WCD use (a positive change of at least 5 percentage points in EF), or has a borderline EF of 30-35%, but still has continued SCD risk (EF ≤ 35%). These patients are expected to continue to use the WCD for an additional 3 months.
measure: Meet GDMT
time frame: 180 days
description: Patient not improved from start of WCD use (no change or worsening of EF), EF<30% and has continued high SCD risk. These patients will either continue the WCD for an additional 90 days if not on GDMT, or receive an ICD if already on GDMT.
measure: Incidence of other arrhythmias
time frame: 180 days
description: Observe the incidence of other arrhythmias during WCD use, such as asystole and supra-ventricular arrhythmias that are recorded by the device.
measure: Determine the number of ICD treatment shocks
time frame: 180 days
description: Collect ICD treatment data for those who receive an ICD, and evaluate for appropriateness as assessed by ECG recordings.
measure: Efficacy in ventricular arrhythmias
time frame: 180 days
description: Observe the effectiveness of the wearable defibrillator worn by this population in treating ventricular arrhythmias. Clinical outcomes data from any defibrillation or cardiac event will be collected, including device data on appropriate arrhythmia detection and shock delivery.
measure: Mortality following hospital discharge
time frame: 360 days
description: Evaluate the effect of wearable defibrillators on 90,180, 270, and 360-day mortality following discharge in HF patients. Assessment of survival will be made at these time points for those entered into the study. A mortality review will be conducted to group all deaths as cardiac or non-cardiac, and sudden or non-sudden.
measure: Cost of healthcare utilization
time frame: 360 days
description: Assess cost of healthcare utilization (emergency room visits, hospitalizations, doctor visits etc.) on all patients during the period of the study.
measure: Complications from extended use
time frame: 360 days
description: The safety objectives will be to compare complications from extended use of the WCD with those of the ICD during the study timeframe.
intervention type: Device
intervention name: Wearable Cardioverter Defibrillator
description: LifeVest Wearable Cardioverter Defibrillator
other name: LifeVest
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mike Osz
role: Study Director
affiliation: Director, Clinical Operations
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country: Austria
country: France
country: Germany
country: United States
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Heart Arrest
mesh term: Death, Sudden, Cardiac
mesh term: Death
sharing ipd: No
submitted: June 27, 2023