The purpose of this clinical study is to explore the long-term efficacy and safety of the Corheart 6 Left Ventricular Assist System (LVAS) as a treatment for patients with advanced heart failure. The study will be a single-arm, prospective, single-center, non-blinded, and non-randomized study with a follow-up duration of five years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Implantation of left ventricular assist device for hemodynamic support
Nanjing First Hospital
Nanjing, Jiangsu, China
Device implantaion success rate at 24 months post-implantation
Device implantation success is defined as: * A. Electively transplanted or explanted prior to 24 months or * B. Alive at 24 months, and * I. Have not experienced a stroke with a modified Rankin Score \> 3, and * II. Have not received a device replacement or exchange due to a device malfunction, and * III. Have not received an urgent transplant due to a device malfunction.
Time frame: Up to 24 months post-implantation
Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23)
Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms.
Time frame: Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation
Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L) questionnaire
The scores from the 5 dimensions are summed for the total score, with higher scores indicating more problems and a worse quality of life.
Time frame: Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation
Functional status as measured by the Six Minute Walk Test (6MWT)
The more meters a patient can walk over baseline indicates improvement in functional status.
Time frame: Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation
Functional status as measured by the New York Heart Association (NYHA) Classification
NYHA class categorizes patients by the severity of their heart failure symptoms. As the class increases, the degree of symptoms is more severe indicating worse functional status.
Time frame: Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation
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Stroke severity as assessed with the National Institutes of Health Stroke Scale (NIHSS) score
Scores range from 0 to 42. Higher scores indicate more severe disability
Time frame: Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation, and as a stoke event occurs, from baseline to 24 months post-implantation
Stroke severity as assessed by the modified Rankin Scale (mRS) score
Scores range from 0 to 6. Higher scores indicate more severe disability
Time frame: Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation, and as a stoke event occurs, from baseline to 24 months post-implantation
Adverse events
Frequency and incidence of all anticipated adverse events
Time frame: As they occur, from baseline to 24 months post-implantaion
Device-related re-operations
Frequency and incidence of all device-related re-operations
Time frame: As they occur, from baseline to 24 months post-implantaion
Device-related re-hospitalizations
Frequency and incidence of all device-related re-hospitalizations
Time frame: As they occur, from initial hospital discharge to 24 months post-implantation
Overall survival
Overall survival at 60 months post-implantation
Time frame: Up to 60 months post-implantation