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This study is to evaluate the safety and effectiveness of the Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) when used for the treatment of advanced refractory heart failure.
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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 advanced refractory heart failure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corheart 6 Left Ventricular Assist System | Device | Implantation of left ventricular assist device for hemodynamic support |
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| Measure | Description | Time Frame |
|---|---|---|
| Survival [ Time Frame: 6 months ] | Patients survived with the device for at least 6 months without disabling stroke (disabling stroke disabling stroke defined as a mRS Score > 3 at 60 days after stroke) and without reoperation (replacement or removal) due to device problems. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (EQ-5D-5L) | The EQ-5D-5L is a standardized measure of health status developed by the EuroQol Group. Patients describe their perceived health status using an analog scale with 0 as the worst health the patient can imagine and 100 as the best health (Visual Analog Score). The patients' scores at one, three and six months were compared to their baseline scores and the resulting positive scores indicated improved quality of life. |
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Inclusion Criteria:
Age ≥ 18 years
Patient or legal representative has signed Informed Consent Form (ICF)
BSA ≥ 1.0 m2
Females of child bearing age must agree to use adequate contraception
Patients with NYHA Class IV heart failure symptoms who have failed to be reversed by previous standardized oral treatment with anti-heart failure drugs (ACEI, beta-blockers and diuretics)
LVEF ≤ 30%,and at least one of the following conditions occurs:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100037 | China |
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| Baseline, Month 1, Month 3, Month 6 |
| Functional Status - Six Minute Walk Test (6MWT) | The Six Minute Walk Test(6MWT)measures the distance that a patient can walk in a period of 6 minutes.The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status. | [ Time Frame: Baseline, Month 1, Month 3, Month 6 ] |
| New York Heart Association (NYHA) Classification | NYHA classification relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort | Baseline, Month 1, Month 3, Month 6 |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms. | Baseline, Month 1, Month 3, Month 6 |