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PARACHUTE China Approval Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02240940
Recruitment Status : Terminated (Company closed)
First Posted : September 16, 2014
Last Update Posted : June 22, 2017
Guangzhou Chuangsi Medical Technology Co., Ltd.
Peking University
Information provided by (Responsible Party):
CardioKinetix, Inc

Tracking Information
First Submitted Date  ICMJE September 5, 2014
First Posted Date  ICMJE September 16, 2014
Last Update Posted Date June 22, 2017
Study Start Date  ICMJE September 2014
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2014)
Reduction of LVESVi [ Time Frame: 3 months ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2014)
  • Major Adverse Cardiac Events [ Time Frame: 3 months ]
    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.
  • Improvement in NYHA Class [ Time Frame: 3 months ]
    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.
  • Improvement in 6 minute walk test [ Time Frame: 3 months ]
    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.
  • Improvement in Quality of Life [ Time Frame: 3 months ]
    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.
  • Procedural Success [ Time Frame: Day 0 ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 12, 2014)
Long-term Safety [ Time Frame: 6 months and 1 year ]
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.
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title  ICMJE PARACHUTE China Approval Trial
Official Title  ICMJE PARACHUTE China: Multi-center, Prospective, Single-arm Clinical Evaluation of the Safety and Efficacy of the Parachute Percutaneous Left Ventricle Partitioning System
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ischemic Heart Failure
Intervention  ICMJE Device: Parachute Implant
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.
Study Arms  ICMJE Experimental: Parachute Implant
Appropriate patients meeting inclusion / exclusion will be implanted with the Parachute device after screening with transthoracic echocardiography (TTE) and cardiac CT or MRI.
Intervention: Device: Parachute Implant
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 12, 2014)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years ≤ 79 years
  • BMI < 40'
  • Left ventricle ejection fraction ≤40% and ≥15%
  • Previous transthoracic echocardiography showing LV MI structural heart dysfunction represented by LV wall motion abnormalities (WMA)
  • Appearance of ischemic heart failure symptoms (NYHA class II to "nonhospitalized" class IV) following anterior wall infarction and within the previous 60 days
  • Left ventricle must have the appropriate anatomical structures (size and shape); cardiac CT and left ventricular angiography are used to confirm that implanting an appropriate Parachute device is possible
  • Have received appropriate treatment according to ACC/AHA guidelines
  • Subject or his/her legal representative informed of the nature of the study and consented to participate in all the provisions of the trial, signed the EC-approved informed consent form, agreed to undergo the post-surgery treatment plan and follow-up requirements, and is able to complete the follow-up and required follow-up examinations.

Exclusion Criteria:

  • Significant ventricle wall motion abnormalities in addition to the anteroapical region
  • Valvular stenosis or regurgitation (tricuspid, aortic, or mitral valve) > 2+
  • Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
  • Requires long-term dialysis for end-stage renal disease or onset of sepsis or active endocarditis
  • Life expectancy at time of enrollment and hospitalization <1 year
  • Known allergies or contraindications to aspirin, heparin, warfarin, nitinol (titanium and nickel alloy), or sensitivity to contrast agents, that cannot be sufficiently treated with medication before surgery
  • Cardiogenic shock within 72 hours of screening
  • Pregnant or planning to become pregnant during the study period
  • Participated in a clinical trial of another drug or medical device within 30 days of screening
  • The researchers have determined that patient compliance is poor and that the person will be unable to complete the study in accordance with the requirements
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02240940
Other Study ID Numbers  ICMJE RD1735
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party CardioKinetix, Inc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE CardioKinetix, Inc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Guangzhou Chuangsi Medical Technology Co., Ltd.
  • Peking University
Investigators  ICMJE
Study Chair: Runlin Gao, MD Chinese Academy of Medical Sciences, Fu Wai Hospital
Principal Investigator: Yuejin Yang, MD Chinese Academy of Medical Sciences, Fu Wai Hospital
Principal Investigator: Yuong Huo, MD Peking University First Hospital
PRS Account CardioKinetix, Inc
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP