DuoCor 2 DOMINATE Study (NCT07233876) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
DuoCor 2 DOMINATE Study
Germany50 participantsStarted 2026-04-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 3\. Patient has left heart failure with at least one of the following criteria:
* Left ventricular ejection fiction (LVEF) ≤ 30%;
* Pulmonary capillary wedge pressure (PCWP) \> 15mmHg.
* 4\. Patient has severe, irreversible biventricular heart failure and is eligible for biventricular mechanical circulatory support based on the ISHLT guideline. This includes at least two of the following hemodynamic and/or echocardiographic measurements:
* Right ventricular ejection fraction (RVEF)≤ 30%;
* Right ventricular stroke work index (RVSWI)≤ 0.25 mmHg\*L/m2;
* Tricuspid annular plane systolic excursion (TAPSE)≤ 14 mm;
* Right ventricular (RV) to left ventricular (LV) end-diastolic diameter ratio\> 0.72;
* Central venous pressure (CVP)\> 15 mmHg;
* CVP to PCWP ratio\> 0.63;
* Tricuspid insufficiency grade 2-4;
* Pulmonary artery pressure index (PAPi)\< 2;
* 5\. Patient or its legal representative has signed the informed consent, has full understanding of procedures and the study, and is committed to following study requirements.
Exclusion Criteria:
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite of survival at 6 months post-implantation