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
Qualifiers
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
Treatments tested in this trial
- DuoCor Ventricular Assist System
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov