Clinical trial NCT02240940: 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
Overall status: TERMINATED
Phase: NA
Conditions: Ischemic Heart Failure
Keywords: Heart Failure
Volume Reduction
Pressure Reduction
Ischemic Heart Failure
LAD Infarct
Lead sponsor: CardioKinetix, Inc
Sponsor class: INDUSTRY
Collaborators: name: Guangzhou Chuangsi Medical Technology Co., Ltd.
name: Peking University
First posted: 2014-09-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reduction of LVESVi
timeFrame: 3 months
Secondary outcomes:
measure: Major Adverse Cardiac Events
timeFrame: 3 months
measure: Improvement in NYHA Class
timeFrame: 3 months
measure: Improvement in 6 minute walk test
timeFrame: 3 months
measure: Improvement in Quality of Life
timeFrame: 3 months
measure: Procedural Success
timeFrame: Day 0
Other outcomes:
measure: Long-term Safety
timeFrame: 6 months and 1 year
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences Fu Wai Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University Medical College
state: Zhejiang
city: Shanghai
country: China
facility: 10th People's Hospital Affiliated to Tongji University
city: Shanghai
country: China
facility: Shanghai Jiaotong University School of Medicine Ruijin Hospital
city: Shanghai
country: China
facility: Zhongshang Hospital of Fudan University
city: Shenyang City
country: China
facility: General Hospital of Shenyang Military Region
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fu Wai Hospital
name: Runlin Gao, MD
role: STUDY_CHAIR
affiliation: Chinese Academy of Medical Sciences, Fu Wai Hospital
name: Yuejin Yang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University First Hospital
name: Yuong Huo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.