ClinicalTrials.gg
Not yet recruitingNCT07757451Updated Aug 11, 2026

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

An interventional study of DuoCor 2 Ventricular Assist System (DuoCor 2 VAS) in Advanced Heart Failure, sponsored by Shenzhen Core Medical Technology CO.,LTD.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Shenzhen Core Medical Technology CO.,LTD. · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 375 studies in Heart Failure with a site in China — 162 open to participants now, 182 under way, 18 of them phase 3. Heart Failure · China.

Planned enrollment
176th of 246
64 · median 127
Started
2026
with 41 others
No phase
115 of 375
51 open now
Primary completion
2028-07
later than 144 of 181 live
Registered
370th of 375
by date

Among the 375 studies in Heart Failure with a site in China, this one is the 176th largest by planned enrollment of the 246 interventional ones that give a count, is one of 42 that started in 2026, is one of 115 with no phase, reaches primary completion later than 144 of the 181 other live ones, and was the 370th registered.

Heart Failure

6,332 studies on the registry are indexed under Heart Failure; 1,392 are open to participants now.

Browse Heart Failure studies →

Open to participants now

162 of the 375 studies in Heart Failure with a site in China are open now. Recruiting first, the newest first:

157 more — sign in →

All 162 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 966 Heart Failure studies recruiting now, 689 (71%) set no upper age limit and 89 (9%) stop at 75 or younger; 63 take children under 18; 96 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 375 studies in Heart Failure with a site in China, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Advanced Heart Failure

Browse trials for

Keywords

  • Biventricular Heart Failure
  • Biventricular Assist Device
  • Mechanical Circulatory Support
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

    • (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 , has full understanding of procedures and the study, and is committed to following study requirements.

Exclusion criteria

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 \< 100*10\^9/L or ≥ 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 > 3.0 mg/dL or cirrhosis confirmed by imaging or positive ;
    • (GFR) \< 30 mL/min/1.73 m2 or renal replacement therapy dependence;
    • History of severe (COPD) defined by /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 , 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.
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
64 participants (estimated)

Study arms

  • 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)

Interventions

  • DeviceDuoCor 2 Ventricular Assist System (DuoCor 2 VAS)

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

06

What researchers measure

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.

    Time frame: 6 months

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Baseline, Month 6, Month 12, Month 24

  5. Unplanned Rehospitalization

    Rate of unplanned readmissions to the hospital

    Time frame: 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.

    Time frame: 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)

    Time frame: Week 1, Month 1, Month 3, Month 6, Month 12, Month 18, Month 24

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — No individual participant data will be shared.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Jul 2028, 21 months later.

Of 236 industry-sponsored interventional studies with no phase under Heart Failure, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 62. This study's planned 21 months is below that.

Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 5, 2026
First posted
Aug 11, 2026
StartEst.
Oct 2026
Primary completionEst.
Jul 2028
CompletionEst.
Jan 2030
Last update
Aug 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07757451
Responsible party
Sponsor
First posted
Aug 11, 2026
Start date
Oct 2026 (estimated)
Primary completion
Jul 2028 (estimated)
Completion
Jan 2030 (estimated)
Last update
Aug 11, 2026

Study contacts

Lily Shi
Contact
shixiaoli@coretechmed.com
+86 1341860135
Nianguo Dong
principal investigator · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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