AzTrials
AzTrials

Advanced Heart FailureNCT07757451

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

A study testing DuoCor 2 Ventricular Assist System (DuoCor 2 VAS) in people with Advanced Heart Failure, run by Shenzhen Core Medical Technology CO.,LTD. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Heart Failure
What is being tested?
DuoCor 2 Ventricular Assist System (DuoCor 2 VAS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteChina
Study dates
Oct 2026to Jan 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 24Show fewer
  • 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.

Who cannot join

  • 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.
Show all 25Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lily Shi contact

+86 1341860135

shixiaoli@coretechmed.com

China1 site

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

    Wuhan, Hubei, 430000

    Nianguo Dong, +86 13971181551, dongnianguo@hotmail.com

Other trials in China

About this study

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.

Being tested
DuoCor 2 Ventricular Assist System (DuoCor 2 VAS)
Keywords
Biventricular Heart Failure, Biventricular Assist Device, Mechanical Circulatory Support

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DuoCor 2 Ventricular Assist System (DuoCor 2 VAS)Device

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

Study groups in NCT07757451
Study groupRoleWhat they receive
DuoCor 2 VASExperimentalThe DuoCor 2 Ventricular Assist System (DuoCor 2 VAS) to be used on patients with advanced biventricular heart failure
Receives: Device: DuoCor 2 Ventricular Assist System (DuoCor 2 VAS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (7)

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

    The more meters a patient can walk over baseline indicates improvement in functional status.

    Measured: Baseline, Month 6, Month 12, Month 24

  2. 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.

    Measured: Baseline, Month 6, Month 12, Month 24

  3. 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.

    Measured: Baseline, Month 6, Month 12, Month 24

  4. 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.

    Measured: Baseline, Month 6, Month 12, Month 24

  5. Unplanned Rehospitalization

    Rate of unplanned readmissions to the hospital

    Measured: Month 3, Month 6, Month 12, Month18, Month 24

  6. 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.

    Measured: Week 1, Month 1, Month 3, Month 6, Month 12, Month 18, Month 24

  7. Adverse Events

    Frequency and incidence of all Adverse Event as defined in (INTERMACS Adverse Events Definition Date: 10/11/2021)

    Measured: Week 1, Month 1, Month 3, Month 6, Month 12, Month 18, Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionJul 2028 (estimated)
  4. Study completionJan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07757451
Sponsor's protocol ID
COREMED_CN_DuoCor 2 VAS
Status last verified
Aug 2026
First submitted
5 Aug 2026
Last updated
11 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No individual participant data will be shared.

Questions about this trial

What is this clinical trial studying?

A study testing DuoCor 2 Ventricular Assist System (DuoCor 2 VAS) in people with Advanced Heart Failure, run by Shenzhen Core Medical Technology CO.,LTD. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lily Shi (+86 1341860135, shixiaoli@coretechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free survival rate at 6 months post-implantation (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07757451.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in