The objective of this clinical investigation is to evaluate the safety and efficacy of the DuoCor 2 Ventricular Assist System (DuoCor 2 VAS) in subjects with advanced biventricular heart failure requiring circulatory support. Each subject receiving the DuoCor 2 VAS will be evaluated at 6 months (180 days) for primary and secondary endpoints with further follow-up assessments up to 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Implantation of the DuoCor 2 Ventricular Assist System for mechanical circulatory support.
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Event-free survival rate at 6 months post-implantation
Event-free survival rate at 6 months post-implantation. Events are defined as all-cause death, ECMO implantation, and IABP implantation.
Time frame: 6 months
Function Status as measured by Six Minute Walk Test (6MWT)
The more meters a patient can walk over baseline indicates improvement in functional status.
Time frame: Baseline, Month 6, Month 12, Month 24
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, Month 6, Month 12, Month 24
Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L)
The scores from the 5 dimensions are summed for the total score which ranges from 5 to 25 with higher scores indicating more problems and a worse quality of life.
Time frame: Baseline, Month 6, Month 12, Month 24
Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
The scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms.
Time frame: Baseline, Month 6, Month 12, Month 24
Unplanned Rehospitalization
Rate of unplanned readmissions to the hospital
Time frame: Month 3, Month 6, Month 12, Month18, Month 24
Event-free survival rate within 24 months post-implantation.
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Event-free survival rate within 24 months post-implantation. Events are defined as all-cause death, ECMO implantation, and IABP implantation.
Time frame: Week 1, Month 1, Month 3, Month 6, Month 12, Month 18, Month 24
Adverse Events
Frequency and incidence of all Adverse Event as defined in (INTERMACS Adverse Events Definition Date: 10/11/2021)
Time frame: Week 1, Month 1, Month 3, Month 6, Month 12, Month 18, Month 24