DuoCor 2 DOMINATE Study
ConditionAdvanced Heart Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenzhen Core Medical Technology CO.,LTD.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Age ≥ 18 years and ≤ 75 years
2. Patient is inotrope dependent, OR has a Cardiac Index (CI) < 2.2 L/min/m2, while not on inotropes
Left ventricular ejection fiction (LVEF) ≤ 30%;
Pulmonary capillary wedge pressure (PCWP) > 15mmHg.
Disqualifiers
1. Known intolerance to anticoagulant or antiplatelet therapies.
2. Etiology of heart failure due to restrictive or constrictive physiology (e.g., hypertrophic cardiomyopathy, cardiac amyloidosis /senile or other infiltrative heart disease).
3. Coagulopathy defined by platelets < 100k/µl or INR ≥ 1.5 not due to anticoagulant therapy.
4. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.
Trial design
Design model
Single group
Treatments tested in this trial
DuoCor Ventricular Assist System
DeviceImplantation of the DuoCor Ventricular Assist System for mechanical circulatory support.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: DuoCor VASExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 62
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 63
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 64
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 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: