DuoCor 2 DOMINATE Study

NCT07233876 | Not Yet Recruiting DMC

• 1 other identifier: COREMED_EU_DuoCor
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Heart Failure

Keywords

Mechanical Circulatory Support; Biventricular Heart Failure; Biventricular Assist Device

Outcome Measures

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).

  6 months

Secondary Outcomes (5)

• Function Status as measured by Six Minute Walk Test (6MWT)

  Baseline, Month 3, Month 6

• Functional status as measured by the New York Heart Association (NYHA) Classification

  Baseline, Month 3, Month 6

• Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L)

  Baseline, Month 3, Month 6

• Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

  Baseline, Month 3, Month 6

• Adverse Events

  As they occurred, from Baseline to Month 6

Study Arms (1)

DuoCor VAS

EXPERIMENTAL

The DuoCor Ventricular Assist System (DuoCor VAS) to be used on patients with advanced biventricular heart failure

Device: DuoCor Ventricular Assist System

Interventions

DuoCor Ventricular Assist System DEVICE

Implantation of the DuoCor Ventricular Assist System for mechanical circulatory support.

DuoCor VAS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≥ 18 years and ≤ 75 years
• \. Patient is inotrope dependent, OR has a Cardiac Index (CI) \< 2.2 L/min/m2, while not on inotropes
• \. 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.
• \. 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;
• \. 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.

You may not qualify if:

• \. Known intolerance to anticoagulant or antiplatelet therapies.
• \. Etiology of heart failure due to restrictive or constrictive physiology (e.g., hypertrophic cardiomyopathy, cardiac amyloidosis /senile or other infiltrative heart disease).
• \. Coagulopathy defined by platelets \< 100k/µl or INR ≥ 1.5 not due to anticoagulant therapy.
• \. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.
• \. Presence of temporary mechanical circulatory support such as Impella (all types) or IABP with a duration greater than 21 days.
• \. Presence of ECMO with a duration greater than 10 days.
• \. Patient is implanted with durable mechanical circulatory support (LVAD or RVAD) and has refused to switch to the study device.
• \. Patient experienced cerebrovascular accident (CVA) within 3 months of eligibility evaluation.
• \. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
• Total bilirubin \> 3.0 mg/dL or cirrhosis confirmed by imaging or positive biopsy;
• Glomerular filtration rate (GFR) \< 30 mL/min/1.73 m2 or renal replacement therapy dependence;
• History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC \< 0.7, or FEV1 \< 50% predicted.
• Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration;
• \. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units.
• \. Severe systemic light-chain amyloidosis.

Sponsors & Collaborators

• Shenzhen Core Medical Technology CO.,LTD.: lead

Study Sites (1)

Medizinische Hochschule Hannover

Hanover, Germany

Location

Study Officials

• Jan D Schmitto

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lily Shi

CONTACT

+86 13418601356; shixiaoli@coretechmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)