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

NCT07757451 | Not Yet Recruiting

• 1 other identifier: COREMED_CN_DuoCor 2 VAS
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Heart Failure

Keywords

Biventricular Heart Failure; Biventricular Assist Device; Mechanical Circulatory Support

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

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

  Baseline, Month 6, Month 12, Month 24

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

  Baseline, Month 6, Month 12, Month 24

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

  Baseline, Month 6, Month 12, Month 24

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

  Baseline, Month 6, Month 12, Month 24

• Unplanned Rehospitalization

  Month 3, Month 6, Month 12, Month18, Month 24

Study Arms (1)

DuoCor 2 VAS

EXPERIMENTAL

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)

Interventions

DuoCor 2 Ventricular Assist System (DuoCor 2 VAS) DEVICE

Implantation of the DuoCor 2 Ventricular Assist System for mechanical circulatory support.

DuoCor 2 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:

• years ≤ Age ≤ 75 years
• INTERMACS Class 1-2
• Patient is inotrope dependent, OR has a Cardiac Index (CI) \< 2.2 L/min/m2, while not on inotropes
• \. Patient has reduced exercise capacity due to cardiac factors with at least one of the following criteria:
• Unable to exercise
• minute walking test (6MWT) \< 300 meters
• Patient has right heart failure related symptoms such as lower limbs edema, jugular vein distension
• Patient has advanced, irreversible biventricular heart failure and is deemed to be eligible for biventricular mechanical circulatory support by clinical expertise.
• a: advanced left heart failure
• Left ventricular ejection fraction (LVEF) ≤ 30%;
• Pulmonary capillary wedge pressure (PCWP) \> 15mmHg.
• b: 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;

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 \< 100\*10\^9/L 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.
• Moderate to severe aortic valve regurgitation or pulmonary valve regurgitation, and refusal of bioprosthetic valve replacement.
• Presence of mechanical aortic valve or pulmonary valve, and refusal of bioprosthetic valve replace.
• \. 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 significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.
• \. 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.

Sponsors & Collaborators

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

Study Sites (1)

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

Study Officials

• Nianguo Dong

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lily Shi

CONTACT

+86 1341860135; 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: August 5, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)