A Prospective, Multicenter,Single-arm Study of DuoCor 2 Ventricular Assist System for the Treatment of Advanced Biventricular Heart Failure

The objective of this clinical investigation is to evaluate the safety and efficacy of the DuoCor 2 Ventricular Assist System (DuoCor 2 VAS) in subjects with advanced biventricular heart failure requiring circulatory support.

Each subject receiving the DuoCor 2 VAS will be evaluated at 6 months (180 days) for primary and secondary endpoints with further follow-up assessments up to 2 years.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Heart Failure
• Intervention / Treatment: Device: DuoCor 2 Ventricular Assist System (DuoCor 2 VAS)

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lily Shi; Phone Number: +86 1341860135; Email: shixiaoli@coretechmed.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Contact: Nianguo Dong; Phone Number: +86 13971181551; Email: dongnianguo@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1.18 years ≤ Age ≤ 75 years
• 2.INTERMACS Class 1-2
• 3.Patient is inotrope dependent, OR has a Cardiac Index (CI) < 2.2 L/min/m2, while not on inotropes

• 4. Patient has reduced exercise capacity due to cardiac factors with at least one of the following criteria:

  • Unable to exercise
  • 6-minute walking test (6MWT) < 300 meters
• 5.Patient has right heart failure related symptoms such as lower limbs edema, jugular vein distension
• 6.Patient has advanced, irreversible biventricular heart failure and is deemed to be eligible for biventricular mechanical circulatory support by clinical expertise.

• 6a: advanced left heart failure

  • Left ventricular ejection fraction (LVEF) ≤ 30%;
  • Pulmonary capillary wedge pressure (PCWP) > 15mmHg.

• 6b: severe right heart failure despite guideline-directed medical therapy. This includes at least one evaluation index of right ventricular function and at least one evaluation index of volume load or structural abnormality:

  • Evaluation index of right ventricular function:
• Right ventricular ejection fraction (RVEF)≤ 30%;
• Right ventricular stroke work index (RVSWI)≤ 0.25 mmHg*L/m2;

• Right ventricle fractional area change(RVFAC) < 30%;

  • Evaluation index of volume load or structural abnormality:
• Central venous pressure (CVP)> 15 mmHg;
• CVP to PCWP ratio> 0.63;
• Moderate to severe tricuspid regurgitation;
• Right ventricular (RV) to left ventricular (LV) end-diastolic diameter ratio> 0.72;
• Tricuspid annular plane systolic excursion (TAPSE)≤ 14 mm;
• Pulmonary artery pressure index (PAPi)< 2.
• 7.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 platelets < 100*10^9/L 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.
• 5. Presence of temporary mechanical circulatory support such as Impella (all types) or IABP with a duration greater than 21 days.
• 6. Presence of ECMO with a duration greater than 10 days.
• 7.Moderate to severe aortic valve regurgitation or pulmonary valve regurgitation, and refusal of bioprosthetic valve replacement.
• 8.Presence of mechanical aortic valve or pulmonary valve, and refusal of bioprosthetic valve replace.
• 9. Patient is implanted with durable mechanical circulatory support (LVAD or RVAD) and has refused to switch to the study device.
• 10. Patient experienced cerebrovascular accident (CVA) within 3 months of eligibility evaluation.
• 11. Presence of significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.

• 12. 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, and FEV1 < 50% predicted.
• 13. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units.
• 14. Severe systemic light-chain amyloidosis.
• 15. Blood stream infection within 7 days. Positive blood cultures reflective of contaminants (e.g., Staphylococcus epidermidis) will not be considered an exclusion.
• 16. Sepsis
• 17. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) > 5 cm in diameter.
• 18.Any condition other than HF that could limit survival to less than 24 months.
• 19.Positive pregnancy test if of childbearing potential, lactating mothers.
• 20.Presence of psychiatric disorders, irreversible cognitive impairment, or psychosocial issues that may compromise their ability to comply with the study protocol and management requirements for implantable ventricular assist devices, or brain death due to any cause.
• 21. Participation in any other clinical investigation that is likely to confound study results or affect the study.
• 22.Ineligibly based on physician's judgement due to other severe conditions or other conditions which can interfere with subject's compliance to the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DuoCor 2 VAS; The DuoCor 2 Ventricular Assist System (DuoCor 2 VAS) to be used on patients with advanced biventricular heart failure	Device: DuoCor 2 Ventricular Assist System (DuoCor 2 VAS); Implantation of the DuoCor 2 Ventricular Assist System for mechanical circulatory support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event-free survival rate at 6 months post-implantation	Event-free survival rate at 6 months post-implantation. Events are defined as all-cause death, ECMO implantation, and IABP implantation.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Function Status as measured by Six Minute Walk Test (6MWT)	The more meters a patient can walk over baseline indicates improvement in functional status.	Baseline, Month 6, Month 12, Month 24
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.	Baseline, Month 6, Month 12, Month 24
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.	Baseline, Month 6, Month 12, Month 24
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.	Baseline, Month 6, Month 12, Month 24
Unplanned Rehospitalization	Rate of unplanned readmissions to the hospital	Month 3, Month 6, Month 12, Month18, Month 24
Event-free survival rate within 24 months post-implantation.	Event-free survival rate within 24 months post-implantation. Events are defined as all-cause death, ECMO implantation, and IABP implantation.	Week 1, Month 1, Month 3, Month 6, Month 12, Month 18, Month 24
Adverse Events	Frequency and incidence of all Adverse Event as defined in (INTERMACS Adverse Events Definition Date: 10/11/2021)	Week 1, Month 1, Month 3, Month 6, Month 12, Month 18, Month 24

Collaborators and Investigators

• Sponsor: Shenzhen Core Medical Technology CO.,LTD.
• Investigators: Principal Investigator: Nianguo Dong, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: August 5, 2026
• First Submitted That Met QC Criteria: August 5, 2026
• First Posted (Actual): August 11, 2026

Study Record Updates

• Last Update Posted (Actual): August 11, 2026
• Last Update Submitted That Met QC Criteria: August 5, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Mechanical Circulatory Support; Biventricular Heart Failure; Biventricular Assist Device
• Other Study ID Numbers: COREMED_CN_DuoCor 2 VAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No