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| Name | Class |
|---|---|
| Guangzhou Chuangsi Medical Technology Co., Ltd. | UNKNOWN |
| Peking University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parachute Implant | Experimental | Appropriate patients meeting inclusion / exclusion will be implanted with the Parachute device after screening with transthoracic echocardiography (TTE) and cardiac CT or MRI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parachute Implant | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term Safety | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Runlin Gao, MD | Chinese Academy of Medical Sciences, Fu Wai Hospital | Study Chair |
| Yuejin Yang, MD | Chinese Academy of Medical Sciences, Fu Wai Hospital | Principal Investigator |
| Yuong Huo, MD | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences Fu Wai Hospital | Beijing | Beijing Municipality | China | |||
| Peking University First Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33879206 | Derived | 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. | |
| 27569231 | Derived |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 3 months |
| 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. | 3 months |
| 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. | 3 months |
| 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. | 3 months |
| 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. | Day 0 |
| 6 months and 1 year |
| Beijing |
| Beijing Municipality |
| China |
| Second Affiliated Hospital of Zhejiang University Medical College | Hangzhou | Zhejiang | 310016 | China |
| 10th People's Hospital Affiliated to Tongji University | Shanghai | China |
| Shanghai Jiaotong University School of Medicine Ruijin Hospital | Shanghai | China |
| Zhongshang Hospital of Fudan University | Shanghai | China |
| General Hospital of Shenyang Military Region | Shenyang | China |
| 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. |