<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/NCT02240940</url>
  </required_header>
  <id_info>
    <org_study_id>RD1735</org_study_id>
    <nct_id>NCT02240940</nct_id>
  </id_info>
  <brief_title>PARACHUTE China Approval Trial</brief_title>
  <official_title>PARACHUTE China: Multi-center, Prospective, Single-arm Clinical Evaluation of the Safety and Efficacy of the Parachute Percutaneous Left Ventricle Partitioning System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CardioKinetix, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Guangzhou Chuangsi Medical Technology Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>CardioKinetix, Inc</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The design of this study is a multi-center, prospective, single-arm clinical trial to&#xD;
      evaluate the safety and efficacy of the Parachute percutaneous left ventricle partitioning&#xD;
      system. The purpose of this trial is to use the Parachute percutaneous left ventricular&#xD;
      partitioning system to isolate the malfunctioning portion of the left ventricle in patients&#xD;
      with symptoms of heart failure due to ischemic heart disease and provide the data required to&#xD;
      gain Chinese regulatory approval.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CardioKinetix has developed a catheter-based treatment method that can be used for treating&#xD;
      patients with heart failure due to ischemic heart disease (left ventricle enlargement after&#xD;
      anterior wall myocardial infarction). This implant device, called the &quot;Parachute,&quot; is a&#xD;
      partitioning membrane placed inside the apex of an enlarged ventricle with motion&#xD;
      abnormalities. The Parachute implant device can then isolate the dysfunctional apex region in&#xD;
      the ventricle, reduce ventricular volume, and improve left ventricular diastolic compliance.&#xD;
&#xD;
      Patients approved for enrollment after screening by cardiac CT or MRI will be implanted with&#xD;
      a Parachute implant device (the study device). Patients will receive all appropriate medical&#xD;
      therapy (AAMT) approved by their physician.&#xD;
&#xD;
      The patient cohort will include patients with heart failure who have wall motion&#xD;
      abnormalities due to previous myocardial infarction, left ventricular ejection fraction ≤40%&#xD;
      and ≥15%, and NYHA class II - IV（non-hospitalized). A maximum of 30 patients will be enrolled&#xD;
      at seven centers. Patients who have passed screening with transthoracic echocardiography&#xD;
      (TTE) and cardiac CT or MRI will be enrolled in the trial.&#xD;
&#xD;
      After confirming that a patient meets the enrollment qualifications with cardiac CT or MRI&#xD;
      evaluation, the patient will be enrolled in the trial and will be implanted with a Parachute&#xD;
      device and treated with warfarin/aspirin anticoagulation therapy.&#xD;
&#xD;
      In the follow-up periods 3 months, 6 months, and 1 year after surgery, clinical evaluation,&#xD;
      TTE testing, functional assessment, 6-minute walk test, and evaluation of adverse events will&#xD;
      be done.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Company closed&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of LVESVi</measure>
    <time_frame>3 months</time_frame>
    <description>The primary outcome measure is comparison of reduction in left ventricle end systolic volume index（LVESVi) after 3 months with baseline LVESVi. Evaluation will be performed via transthoracic echocardiography (TTE) by an independent central ultrasound laboratory (Yale University Clinical Research).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Cardiac Events</measure>
    <time_frame>3 months</time_frame>
    <description>Major adverse cardiac events (MACE) are defined as death from any cause, myocardial infarction, need for elective or urgent cardiac or thoracic aortic surgery or need for use of device or device surgery with a catheter as the basis of interventional therapy, or total renal failure requiring dialysis. The Kaplan-Meier method will be used to evaluate event-free survival after Parachute implantation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in NYHA Class</measure>
    <time_frame>3 months</time_frame>
    <description>All patients will undergo NYHA class evaluation at each time point. At the 3-month follow-up visit, the percentage of patients who have improvement in NYHA class (an improvement of at least 1 in comparison with NYHA class at baseline) will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in 6 minute walk test</measure>
    <time_frame>3 months</time_frame>
    <description>The difference in the distance of the 6-minute walk will be measured by comparing the distance walked at the 3-month follow-up visit with the baseline distance walked.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in Quality of Life</measure>
    <time_frame>3 months</time_frame>
    <description>The difference in EQ5D score by comparing EQ5D score at the 3-month follow-up visit with the EQ5D score at baseline will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural Success</measure>
    <time_frame>Day 0</time_frame>
    <description>Technical success: Success in releasing the Parachute implant or successful completion of surgery.&#xD;
Combined success：The release of all devices with no serious adverse events, additional intervention surgeries, embolisms, technical failures (displacement, loss, etc.) or other problems.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Long-term Safety</measure>
    <time_frame>6 months and 1 year</time_frame>
    <description>Patients will be invited to continue participating in an extended observation study at 6 and 12 months. Patients who agree to participate 6 months and 12 months after surgery will receive the same evaluations as described in the 3-month follow-up visit.&#xD;
Descriptive reports of safety will be made using all the information gathered through the core research and the additional information from the extended observation period.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Ischemic Heart Failure</condition>
  <arm_group>
    <arm_group_label>Parachute Implant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Appropriate patients meeting inclusion / exclusion will be implanted with the Parachute device after screening with transthoracic echocardiography (TTE) and cardiac CT or MRI.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Parachute Implant</intervention_name>
    <description>CardioKinetix's Parachute implant device is suitable for use in isolating the dysfunctional region of the left ventricle in patients with symptoms of heart failure due to ischemic heart disease. Potential benefits of the Parachute implant device are improvement in hemodynamics and the clinical symptoms of heart failure.</description>
    <arm_group_label>Parachute Implant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years ≤ 79 years&#xD;
&#xD;
          -  BMI &lt; 40'&#xD;
&#xD;
          -  Left ventricle ejection fraction ≤40% and ≥15%&#xD;
&#xD;
          -  Previous transthoracic echocardiography showing LV MI structural heart dysfunction&#xD;
             represented by LV wall motion abnormalities (WMA)&#xD;
&#xD;
          -  Appearance of ischemic heart failure symptoms (NYHA class II to &quot;nonhospitalized&quot;&#xD;
             class IV) following anterior wall infarction and within the previous 60 days&#xD;
&#xD;
          -  Left ventricle must have the appropriate anatomical structures (size and shape);&#xD;
             cardiac CT and left ventricular angiography are used to confirm that implanting an&#xD;
             appropriate Parachute device is possible&#xD;
&#xD;
          -  Have received appropriate treatment according to ACC/AHA guidelines&#xD;
&#xD;
          -  Subject or his/her legal representative informed of the nature of the study and&#xD;
             consented to participate in all the provisions of the trial, signed the EC-approved&#xD;
             informed consent form, agreed to undergo the post-surgery treatment plan and follow-up&#xD;
             requirements, and is able to complete the follow-up and required follow-up&#xD;
             examinations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant ventricle wall motion abnormalities in addition to the anteroapical region&#xD;
&#xD;
          -  Valvular stenosis or regurgitation (tricuspid, aortic, or mitral valve) &gt; 2+&#xD;
&#xD;
          -  Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack&#xD;
             (TIA)&#xD;
&#xD;
          -  Requires long-term dialysis for end-stage renal disease or onset of sepsis or active&#xD;
             endocarditis&#xD;
&#xD;
          -  Life expectancy at time of enrollment and hospitalization &lt;1 year&#xD;
&#xD;
          -  Known allergies or contraindications to aspirin, heparin, warfarin, nitinol (titanium&#xD;
             and nickel alloy), or sensitivity to contrast agents, that cannot be sufficiently&#xD;
             treated with medication before surgery&#xD;
&#xD;
          -  Cardiogenic shock within 72 hours of screening&#xD;
&#xD;
          -  Pregnant or planning to become pregnant during the study period&#xD;
&#xD;
          -  Participated in a clinical trial of another drug or medical device within 30 days of&#xD;
             screening&#xD;
&#xD;
          -  The researchers have determined that patient compliance is poor and that the person&#xD;
             will be unable to complete the study in accordance with the requirements&#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>Runlin Gao, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Chinese Academy of Medical Sciences, Fu Wai Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yuejin Yang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese Academy of Medical Sciences, Fu Wai Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yuong Huo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University First Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chinese Academy of Medical Sciences Fu Wai Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Second Affiliated Hospital of Zhejiang University Medical College</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310016</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>10th People's Hospital Affiliated to Tongji University</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Jiaotong University School of Medicine Ruijin Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongshang Hospital of Fudan University</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Shenyang Military Region</name>
      <address>
        <city>Shenyang City</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>September 5, 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>Volume Reduction</keyword>
  <keyword>Pressure Reduction</keyword>
  <keyword>Ischemic Heart Failure</keyword>
  <keyword>LAD Infarct</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</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/NCT02240940
org study id: RD1735
nct id: NCT02240940
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The design of this study is a multi-center, prospective, single-arm clinical trial to
      evaluate the safety and efficacy of the Parachute percutaneous left ventricle partitioning
      system. The purpose of this trial is to use the Parachute percutaneous left ventricular
      partitioning system to isolate the malfunctioning portion of the left ventricle in patients
      with symptoms of heart failure due to ischemic heart disease and provide the data required to
      gain Chinese regulatory approval.
CardioKinetix has developed a catheter-based treatment method that can be used for treating
      patients with heart failure due to ischemic heart disease (left ventricle enlargement after
      anterior wall myocardial infarction). This implant device, called the "Parachute," is a
      partitioning membrane placed inside the apex of an enlarged ventricle with motion
      abnormalities. The Parachute implant device can then isolate the dysfunctional apex region in
      the ventricle, reduce ventricular volume, and improve left ventricular diastolic compliance.

      Patients approved for enrollment after screening by cardiac CT or MRI will be implanted with
      a Parachute implant device (the study device). Patients will receive all appropriate medical
      therapy (AAMT) approved by their physician.

      The patient cohort will include patients with heart failure who have wall motion
      abnormalities due to previous myocardial infarction, left ventricular ejection fraction ≤40%
      and ≥15%, and NYHA class II - IV（non-hospitalized). A maximum of 30 patients will be enrolled
      at seven centers. Patients who have passed screening with transthoracic echocardiography
      (TTE) and cardiac CT or MRI will be enrolled in the trial.

      After confirming that a patient meets the enrollment qualifications with cardiac CT or MRI
      evaluation, the patient will be enrolled in the trial and will be implanted with a Parachute
      device and treated with warfarin/aspirin anticoagulation therapy.

      In the follow-up periods 3 months, 6 months, and 1 year after surgery, clinical evaluation,
      TTE testing, functional assessment, 6-minute walk test, and evaluation of adverse events will
      be done.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Reduction of LVESVi
time frame: 3 months
description: The primary outcome measure is comparison of reduction in left ventricle end systolic volume index（LVESVi) after 3 months with baseline LVESVi. Evaluation will be performed via transthoracic echocardiography (TTE) by an independent central ultrasound laboratory (Yale University Clinical Research).
measure: Major Adverse Cardiac Events
time frame: 3 months
description: Major adverse cardiac events (MACE) are defined as death from any cause, myocardial infarction, need for elective or urgent cardiac or thoracic aortic surgery or need for use of device or device surgery with a catheter as the basis of interventional therapy, or total renal failure requiring dialysis. The Kaplan-Meier method will be used to evaluate event-free survival after Parachute implantation.
measure: Improvement in NYHA Class
time frame: 3 months
description: All patients will undergo NYHA class evaluation at each time point. At the 3-month follow-up visit, the percentage of patients who have improvement in NYHA class (an improvement of at least 1 in comparison with NYHA class at baseline) will be measured.
measure: Improvement in 6 minute walk test
time frame: 3 months
description: The difference in the distance of the 6-minute walk will be measured by comparing the distance walked at the 3-month follow-up visit with the baseline distance walked.
measure: Improvement in Quality of Life
time frame: 3 months
description: The difference in EQ5D score by comparing EQ5D score at the 3-month follow-up visit with the EQ5D score at baseline will be measured.
measure: Procedural Success
time frame: Day 0
description: Technical success: Success in releasing the Parachute implant or successful completion of surgery.
Combined success：The release of all devices with no serious adverse events, additional intervention surgeries, embolisms, technical failures (displacement, loss, etc.) or other problems.
measure: Long-term Safety
time frame: 6 months and 1 year
description: Patients will be invited to continue participating in an extended observation study at 6 and 12 months. Patients who agree to participate 6 months and 12 months after surgery will receive the same evaluations as described in the 3-month follow-up visit.
Descriptive reports of safety will be made using all the information gathered through the core research and the additional information from the extended observation period.
arm group label: Parachute Implant
arm group type: Experimental
description: Appropriate patients meeting inclusion / exclusion will be implanted with the Parachute device after screening with transthoracic echocardiography (TTE) and cardiac CT or MRI.
intervention type: Device
intervention name: Parachute Implant
description: CardioKinetix's Parachute implant device is suitable for use in isolating the dysfunctional region of the left ventricle in patients with symptoms of heart failure due to ischemic heart disease. Potential benefits of the Parachute implant device are improvement in hemodynamics and the clinical symptoms of heart failure.
arm group label: Parachute Implant
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
last name: Runlin Gao, MD
role: Study Chair
affiliation: Chinese Academy of Medical Sciences, Fu Wai Hospital
last name: Yuejin Yang, MD
role: Principal Investigator
affiliation: Chinese Academy of Medical Sciences, Fu Wai Hospital
last name: Yuong Huo, MD
role: Principal Investigator
affiliation: Peking University First Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Heart Failure