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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Implantation of left ventricular assist device for hemodynamic support
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
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.
Time frame: 6 months
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.
Time frame: 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: [ 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
Time frame: 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.
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Time frame: Baseline, Month 1, Month 3, Month 6