Advanced heart failure is a life-threatening condition characterized by the inability of one or both ventricles to maintain adequate blood circulation. In such cases, medical treatments often prove ineffective, necessitating advanced treatment. Heart transplantation is the standard treatment for these patients, but it is severely limited by the shortage of donor hearts. As a result, mechanical circulatory support (MCS) devices are often employed. However, the most common form, the left ventricular assist device (LVAD), is only suitable for patients with isolated left ventricular dysfunction. This leaves a significant treatment gap for patients with biventricular failure. For this population, current options, such as total artificial hearts (TAHs) and biventricular assist devices (BiVADs), are associated with significant challenges, including high rates of adverse events and suboptimal long-term outcomes. The DuoCor Ventricular Assist System (VAS) is a next-generation MCS device specifically developed to address this need by providing simultaneous biventricular support. It incorporates two compact, good hemocompatible blood pumps designed for implantation in both the left and right heart, controlled via a single driveline and external controller. It aims to reduce surgical complexity, improve patient mobility, and minimize complications such as thrombosis and infection. The primary objective of this study is to evaluate the safety and efficacy of the DuoCor VAS as a treatment for advanced biventricular heart failure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Implantation of the DuoCor Ventricular Assist System for mechanical circulatory support.
Medizinische Hochschule Hannover
Hanover, Germany
Composite of survival at 6 months post-implantation
At 6 months post-implantation, composite of survival to transplant, recovery (defined that the removal/switch off all the pump of the DuoCor VAS due to the cardiac recovery), or survival with the device (whether with one or both pumps).
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 3, Month 6
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 3, Month 6
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 3, Month 6
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 3, Month 6
Adverse Events
Frequency and incidence of all anticipated Adverse Event as defined in (INTERMACS Adverse Events Definition Date: 10/11/2021)
Time frame: As they occurred, from Baseline to Month 6
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