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PARACHUTE China Approval Trial

Primary Purpose

Ischemic Heart Failure

Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Parachute Implant
Sponsored by
CardioKinetix, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Failure focused on measuring Heart Failure, Volume Reduction, Pressure Reduction, Ischemic Heart Failure, LAD Infarct

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chinese Academy of Medical Sciences Fu Wai Hospital
  • Peking University First Hospital
  • Second Affiliated Hospital of Zhejiang University Medical College
  • 10th People's Hospital Affiliated to Tongji University
  • Shanghai Jiaotong University School of Medicine Ruijin Hospital
  • Zhongshang Hospital of Fudan University
  • General Hospital of Shenyang Military Region

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Parachute Implant

Arm Description

Appropriate patients meeting inclusion / exclusion will be implanted with the Parachute device after screening with transthoracic echocardiography (TTE) and cardiac CT or MRI.

Outcomes

Primary Outcome Measures

Reduction of LVESVi
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).

Secondary Outcome Measures

Major Adverse Cardiac Events
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
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
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
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
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.

Full Information

First Posted
September 5, 2014
Last Updated
June 21, 2017
Sponsor
CardioKinetix, Inc
Collaborators
Guangzhou Chuangsi Medical Technology Co., Ltd., Peking University
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1. Study Identification

Unique Protocol Identification Number
NCT02240940
Brief Title
PARACHUTE China Approval Trial
Official Title
PARACHUTE China: Multi-center, Prospective, Single-arm Clinical Evaluation of the Safety and Efficacy of the Parachute Percutaneous Left Ventricle Partitioning System
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
Company closed
Study Start Date
September 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CardioKinetix, Inc
Collaborators
Guangzhou Chuangsi Medical Technology Co., Ltd., Peking University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Failure
Keywords
Heart Failure, Volume Reduction, Pressure Reduction, Ischemic Heart Failure, LAD Infarct

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parachute Implant
Arm Type
Experimental
Arm 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(s)
Parachute Implant
Intervention 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.
Primary Outcome Measure Information:
Title
Reduction of LVESVi
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).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Major Adverse Cardiac Events
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.
Time Frame
3 months
Title
Improvement in NYHA Class
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.
Time Frame
3 months
Title
Improvement in 6 minute walk test
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.
Time Frame
3 months
Title
Improvement in Quality of Life
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.
Time Frame
3 months
Title
Procedural Success
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.
Time Frame
Day 0
Other Pre-specified Outcome Measures:
Title
Long-term Safety
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.
Time Frame
6 months and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Runlin Gao, MD
Organizational Affiliation
Chinese Academy of Medical Sciences, Fu Wai Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yuejin Yang, MD
Organizational Affiliation
Chinese Academy of Medical Sciences, Fu Wai Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yuong Huo, MD
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese Academy of Medical Sciences Fu Wai Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Second Affiliated Hospital of Zhejiang University Medical College
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
10th People's Hospital Affiliated to Tongji University
City
Shanghai
Country
China
Facility Name
Shanghai Jiaotong University School of Medicine Ruijin Hospital
City
Shanghai
Country
China
Facility Name
Zhongshang Hospital of Fudan University
City
Shanghai
Country
China
Facility Name
General Hospital of Shenyang Military Region
City
Shenyang City
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
33879206
Citation
Li J, Liu H, Liu Q, Liu C, Xiong W, Ma W, Zhang B, Dong S, Li T. Long-term prognosis analysis of PARACHUTE device implantation in patients with ischemic heart failure: a single-center experience of Chinese patients. J Cardiothorac Surg. 2021 Apr 20;16(1):98. doi: 10.1186/s13019-021-01484-0.
Results Reference
derived
PubMed Identifier
27569231
Citation
Yang YJ, Huo Y, Xu YW, Wang JA, Han YL, Ge JB, Zhang RY, Yan XY, Gao RL. Percutaneous Ventricular Restoration Therapy Using the Parachute Device in Chinese Patients with Ischemic Heart Failure: Three-Month Primary End-point Results of PARACHUTE China Study. Chin Med J (Engl). 2016 Sep 5;129(17):2058-62. doi: 10.4103/0366-6999.189048.
Results Reference
derived

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PARACHUTE China Approval Trial

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