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This study is to evaluate the safety and effectiveness of the Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) used for the treatment of end-stage heart failure.
The Corheart 6 Left Ventricular Assist System (also called "the Corheart 6 LVAS", or "the Corheart 6") is developed and manufactured by Shenzhen Core Medical Technology Co., Ltd. It is indicated for providing short-term and long-term mechanical circulatory support for patients with end-stage heart failure. This prospective, multi-center, and single-arm trial evaluates the safety and effectiveness of the device in treating patients with end-stage heart failure. 50 patients from 12 investigational sites will be enrolled for Corheart 6 VAS implantation and followed for 3 months post-implantation. Following the initial 3-month follow-up, the study was extended to assess the primary endpoint of event-free survival at 24 months, with further follow-up to 5 years to evaluate long-term outcomes. The primary endpoint include the success rate of device implantation at 3 months and event-free survival at 24 months post-implantation. All adverse events will be adjudicated by an independent Clinical Events Committee (CEC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corheart 6 LVAS | Experimental | Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) to be used on patients with end-stage heart failure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corheart 6 Left Ventricular Assist System | Device | Implantation of the Corheart 6 Left Ventricular Assist Device for mechanical circulatory support. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The success rate of device implantation at 3 months. | The success rate of device implantation at 3 months post-implantation. Device implantation success will be met when a patient is still alive on device support, free of disabling stroke (modified Rankin Scale (mRS) > 3), and does not have the device replaced or removed due to device deficiency at 3 months post-implantation. The modified Rankin Scale is a tool used to assess functional disability or dependence in daily activities following a stroke or other neurological condition. It ranges from 0 (No observed neurological symptoms) to 6 (dead). Higher scores indicate more severe functional impairment. | Up to 3 months post-implantation. |
| The event-free survival at 24 months post-implantation. | Survival at 24 months post-implantation free of disabling stroke (mRS >3) or reoperation for device replacement. Subjects who undergo heart transplantation or device explantation due to myocardial recovery are considered to have met the primary endpoint. | Up to 24 months post-implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Functional status as measured by the New York Heart Association (NYHA) Classification | The NYHA (New York Heart Association) Functional Classification is a tool used to assess the severity of heart failure symptoms. It categorizes patients into one of four classes based on their level of activity limitation and symptoms. Class I represents no limitation of physical activity, while Class IV indicates severe limitations even at rest. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shengshou Hu | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, Chinese Academy of Medical Sciences(CAMS) | Beijing | Beijing Municipality | China | |||
| Fujian Medical University Union Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41512307 | Derived | Wang X, Chen H, Du J, Zhou X, Zou L, Huang J, Chen L, Cheng Z, Dong N, Chen X, Liu J, Yang Y, Wang C, Yang Y, Shen Z, Wang H, Hu S. A novel magnetically levitated intrapericardial left ventricular assist system in advanced heart failure-2-year results from a prospective, multi-centre study. Eur J Cardiothorac Surg. 2026 Jan 9:ezag014. doi: 10.1093/ejcts/ezag014. Online ahead of print. |
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At this moment the IPD is not yet available for access and will be updated when it is ready.
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| Baseline, at hospital discharge (within 5 days), and at 3, 6, 12, 24 and 60 months post-implantation. |
| Quality of Life as measured by the EuroQoL-5D-3L (EQ-5D-3L) questionnaire | The EQ-5D-3L assesses health-related quality of life across five dimensions with three severity levels each. The scores from the 5 dimensions are summed for the total score which ranges from 5 to 15 with higher scores indicating more problems and a worse quality of life. | Baseline, at hospital discharge (within 5 days), and at 3, 6, 12, 24 and 60 months post-implantation. |
| Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ-23). | The Kansas City Cardiomyopathy Questionnaire (KCCQ-3) evaluates heart failure patients' health status, including symptoms, physical limitations, social limitations, self-efficacy, and quality of life. Scores range from 0 to 100, with higher scores indicating better health-related quality of life. | Baseline, at hospital discharge (within 5 days), and at 3, 6, 12, 24 and 60 months post-implantation. |
| Functional status as measured by the Six Minute Walk Test (6MWT) | The 6-Minute Walk Test (6MWT) assesses functional capacity and endurance by measuring the distance walked in six minutes. Results vary based on age, gender, and disease severity. Generally, greater distances indicate better functional capacity and endurance. | Baseline, at hospital discharge (within 5 days), and at 3, 6, 12, 24 and 60 months post-implantation. |
| Stroke severity as assessed with the National Institutes of Health Stroke Scale (NIHSS) score. | The National Institutes of Health Stroke Scale measures stroke-related neurological deficits across various domains. Scores range from 0 to 42, with higher scores indicating more severe neurological impairment. Lower scores correlate with better neurological function. | From baseline to 60 months post-implantation. |
| Stroke severity as assessed by the modified Rankin Scale (mRS) score | The modified Rankin Scale is a tool used to assess functional disability or dependence in daily activities following a stroke or other neurological condition. It ranges from 0 (No observed neurological symptoms) to 6 (dead). Higher scores indicate more severe functional impairment. | From baseline to 60 months post-implantation. |
| Adverse Events | Frequency and incidence of all anticipated adverse events. | From baseline to 60 months post-implantation. |
| Fuzhou |
| Fujian |
| China |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | China |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | China |
| The Second XIANGYA Hospital Of Central South University | Changsha | Hunan | China |
| Fuwai Central China Cardiovascular Hospital | Zhengzhou | Hunan | China |
| Nanjing First Hospital | Nanjing | Jiangsu | China |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China |
| Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | China |
| Xijing Hospital of Air Force Medical University | Xi’an | Shanxi | China |
| People's Hospital of Xinjiang Uygur Autonomous Region | Xinjiang | Xinjiang | China |