<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/NCT02241837</url>
  </required_header>
  <id_info>
    <org_study_id>RD1051.B.3</org_study_id>
    <nct_id>NCT02241837</nct_id>
  </id_info>
  <brief_title>PARACHUTE III Pressure Volume Loop Sub-Study</brief_title>
  <acronym>PIII PV Loop</acronym>
  <official_title>PARACHUTE III: A Multinational Trial to Evaluate the Longterm Safety of the Parachute System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CardioKinetix, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CardioKinetix, Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective is to assess the longterm safety of the CardioKinetix Parachute Implant&#xD;
      and Delivery System in the partitioning of the left ventricle in patients with heart failure&#xD;
      due to ischemic heart disease. This sub-study has the additional assessment of improvement in&#xD;
      Pressure Volume Loop and corresponding MSCT to allow improved monitoring of heart improvement&#xD;
      after therapy. The PV Loop Substudy studies he effects of the Parachute Implant on pressure&#xD;
      and volume as functional parameters of the Left Ventricle.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      While current therapies for heart failure (including but not limited to: medical management,&#xD;
      cardiac resynchronization and ICDs) may represent the best treatment available today for the&#xD;
      majority of HF patients, the medical community recognizes that pharmacologic therapy has been&#xD;
      optimized to nearly the extent that is possible, and that any incremental improvements in the&#xD;
      management of HF patients will now come from device based therapies. With this background,&#xD;
      CardioKinetix has developed a catheter-based intravascular approach to ventricular&#xD;
      partitioning using an implantable device. The purpose of this study is to assess the longterm&#xD;
      safety of using the CardioKinetix Parachute device to isolate the malfunctioning portion of&#xD;
      the left ventricle in patients with symptoms of HF due to ischemic heart disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>November 2013</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of long term safety of the Parachute system from baseline to 1 year and annually</measure>
    <time_frame>5 years</time_frame>
    <description>Assessment of long term safety as measured by site-reported device related MACE in real in real-world use of the Parachute Implant through 5 years of clinical follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Left Ventricular Volume Indices between baseline, 6 months, and annually</measure>
    <time_frame>6 months and annually to 5 years</time_frame>
    <description>Change in Left Ventricular Volume Indexes (End Systolic {LVESVI} and End Diastolic {LVEDVI}) as measured by echocardiography from baseline to 6 months and annually to 5 years</description>
  </secondary_outcome>
  <enrollment type="Actual">11</enrollment>
  <condition>Heart Failure</condition>
  <condition>Myocardial Infarction</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will be open to all individuals who meet the inclusion/exclusion&#xD;
        criteria. This is a prospective, multi-center, non-randomized trial.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Candidates for this study must meet ALL of the following inclusion criteria:&#xD;
&#xD;
               1. Akinesis or dyskinesis due to myocardial infarction limited to anteroapical&#xD;
                  region&#xD;
&#xD;
               2. Subject is not hospitalized at time of enrollment.&#xD;
&#xD;
               3. NYHA Class at time of enrollment, either:&#xD;
&#xD;
                    -  NYHA Class III or Ambulatory IV - if predominant during the 3-month period&#xD;
                       prior to enrollment&#xD;
&#xD;
                    -  NYHA Class II - if diagnosed with NYHA Class III or IV during 3-month period&#xD;
                       prior to enrollment&#xD;
&#xD;
               4. LVEF &gt;15 or% and ≤ 40% as measured by echocardiography.&#xD;
&#xD;
               5. Post LV MI structural heart dysfunction represented by LV wall motion abnormality&#xD;
                  (WMA) by echocardiography.&#xD;
&#xD;
               6. Eligible for cardiac surgery&#xD;
&#xD;
               7. Between 18 and 79 years of age (inclusive)&#xD;
&#xD;
               8. Receiving appropriate medical treatment for heart failure according to the&#xD;
                  ACC/AHA 2009 Guideline Update for the Diagnosis and Management of Chronic Heart&#xD;
                  Failure in the Adult during the three months prior to enrollment&#xD;
&#xD;
               9. Provide written informed consent&#xD;
&#xD;
              10. Agree to the protocol-required follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Candidates will be excluded from the study if ANY of the following conditions apply:&#xD;
&#xD;
          1. Untreated clinically significant coronary artery disease requiring intervention.&#xD;
&#xD;
          2. Acute MI (see MI definition) within 60 days of enrollment or patients with suspected&#xD;
             evolving MI at time of enrollment&#xD;
&#xD;
          3. Cardiogenic shock within 72 hours of enrollment&#xD;
&#xD;
          4. Revascularization procedure (PCI or CABG) within 60 days of enrollment&#xD;
&#xD;
          5. Patient has received a pacemaker, ICD, or CRT device within 60 days of enrollment&#xD;
&#xD;
          6. History of aborted sudden cardiac death, if patient has not received an ICD and has&#xD;
             potentially lethal ventricular arrhythmia, VT or VF&#xD;
&#xD;
          7. A known hypersensitivity or contraindication to aspirin, heparin, warfarin, nitinol&#xD;
             (titanium and nickel alloy), or sensitivity to contrast media, which cannot be&#xD;
             adequately pre medicated.&#xD;
&#xD;
          8. Aortic valve replacement or repair&#xD;
&#xD;
          9. Blood dyscrasia, history of bleeding diathesis or coagulopathy, or hypercoagulable&#xD;
             states.&#xD;
&#xD;
         10. Active peptic ulcer or GI bleeding within the past 3 months&#xD;
&#xD;
         11. Patient has suffered a cerebrovascular accident (CVA) or transient ischemic attack&#xD;
             (TIA) within the past 6 months&#xD;
&#xD;
         12. History of Kawasaki's disease&#xD;
&#xD;
         13. Patient on dialysis or expected to require hemodialysis within 12 months&#xD;
&#xD;
         14. Patient has chronic liver disease&#xD;
&#xD;
         15. Impaired renal function that places patient at risk of contrast induced renal failure&#xD;
&#xD;
         16. Ongoing sepsis, including active endocarditis.&#xD;
&#xD;
         17. Co-morbidities associated with a life expectancy of less than 12-months or there are&#xD;
             factors making echo and clinical follow-up difficult (no permanent address, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Simon Redwood, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Thomas' Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OLV Hospital Aalst</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ferrarotto University Hospital Catania</name>
      <address>
        <city>Catania</city>
        <zip>95123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Thomas' Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Italy</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>June 21, 2017</last_update_submitted>
  <last_update_submitted_qc>June 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>heart failure</keyword>
  <keyword>percutaneous</keyword>
  <keyword>interventional cardiology</keyword>
  <keyword>apical remodeling</keyword>
  <keyword>LV dilatation</keyword>
  <keyword>akinesis</keyword>
  <keyword>dyskinesis</keyword>
  <keyword>myocardial infarction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <!-- 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/NCT02241837
org study id: RD1051.B.3
nct id: NCT02241837
lead sponsor: 
has dmc: No
The primary objective is to assess the longterm safety of the CardioKinetix Parachute Implant
      and Delivery System in the partitioning of the left ventricle in patients with heart failure
      due to ischemic heart disease. This sub-study has the additional assessment of improvement in
      Pressure Volume Loop and corresponding MSCT to allow improved monitoring of heart improvement
      after therapy. The PV Loop Substudy studies he effects of the Parachute Implant on pressure
      and volume as functional parameters of the Left Ventricle.
While current therapies for heart failure (including but not limited to: medical management,
      cardiac resynchronization and ICDs) may represent the best treatment available today for the
      majority of HF patients, the medical community recognizes that pharmacologic therapy has been
      optimized to nearly the extent that is possible, and that any incremental improvements in the
      management of HF patients will now come from device based therapies. With this background,
      CardioKinetix has developed a catheter-based intravascular approach to ventricular
      partitioning using an implantable device. The purpose of this study is to assess the longterm
      safety of using the CardioKinetix Parachute device to isolate the malfunctioning portion of
      the left ventricle in patients with symptoms of HF due to ischemic heart disease.
observational model: Case-Only
time perspective: Prospective
measure: Assessment of long term safety of the Parachute system from baseline to 1 year and annually
time frame: 5 years
description: Assessment of long term safety as measured by site-reported device related MACE in real in real-world use of the Parachute Implant through 5 years of clinical follow-up.
measure: Change in Left Ventricular Volume Indices between baseline, 6 months, and annually
time frame: 6 months and annually to 5 years
description: Change in Left Ventricular Volume Indexes (End Systolic {LVESVI} and End Diastolic {LVEDVI}) as measured by echocardiography from baseline to 6 months and annually to 5 years
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
last name: Simon Redwood, MD
role: Principal Investigator
affiliation: St. Thomas' Hospital
facility: 
facility: 
facility: 
country: Belgium
country: Italy
country: United Kingdom
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Myocardial Infarction
mesh term: Infarction