Heart FailureNCT06878508
DuoCor Ventricular Assist System Early Feasibility Study
A study testing DuoCor Ventricular Assist System in people with Heart Failure, run by Shenzhen Core Medical Technology CO.,LTD. at 1 site in China.
Trial summary
Feasibility study of the DuoCor Ventricular Assist System as a treatment for advanced total heart failure patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- DuoCor Ventricular Assist System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who require biventricular mechanical circulatory support, defined by either of the following criteria:
- Persistent total heart failure despite optimal medical management based on current heart failure practice guidelines; OR
- Development of refractory right heart failure following left ventricular assist device (LVAD) implantation, unresponsive to pharmacological interventions for right heart failure.
- Patient has signed the informed consent, has full understanding of procedures, and is committed to following study requirements.
Who cannot join
- Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patient's health status.
- Technical obstacles which pose the implantation as unsuitable, obtaining the body type, body surface area, and anatomical conditions related to the planned implantation site, in the judgment of the experienced investigators.
- Pregnancy.
- Age > 75 years.
- Presence of an active, uncontrolled infection.
- Brain death.
- History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) > 5 cm in diameter.
- Irreversible cognitive dysfunction, psychosocial issues, or psychiatric disease, likely to impair compliance with the study protocol and DuoCor VAS management which, in the opinion of the investigator, could interfere with the ability to manage the therapy.
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
About this study
Official title: Clincial Use of Implantable Ventricular Assist System for Advanced Heart Failure
Feasibility study of the DuoCor Ventricular Assist System as a treatment for advanced total heart failure patients.
- Conditions
- Heart Failure
- Being tested
- DuoCor Ventricular Assist System
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuoCor Ventricular Assist SystemDevice
The DuoCor VAS is used to provide hemodynamic support by shareing some or all the workload of the left and right ventricles during the support period.
| Study group | Role | What they receive |
|---|---|---|
| DuoCor Ventricular Assist System | Experimental | Not described Receives: Device: DuoCor Ventricular Assist System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of survival at 3 months post-implantation
Composite of survival to transplant, recovery (defined as complete/ partial removal or explantation of the DuoCor VAS due to cardiac recovery), or survival with the device at 3 months post-implantation
Measured: 3 months
Secondary outcomes (2)
Hospital redmission rate
Rate of unplanned readmissions to the hospital.
Measured: 3 months
Adverse Events.
Adverse Event as defined in INTERMACS Adverse Events (Definition Date: 10/11/2021)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start4 Jul 2024
- Primary completion17 Mar 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Core Medical Technology CO.,LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878508
- Sponsor's protocol ID
- COREMED_DuoCor
- Status last verified
- Apr 2026
- First submitted
- 6 Mar 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At this moment the IPD is not yet available for access and will be updated when it is ready.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clincial Use of Implantable Ventricular Assist System for Advanced Heart Failure
- ClinicalTrials.gov ID
- NCT06878508
- Acronym / sponsor ID
- COREMED_DuoCor
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Shenzhen Core Medical Technology CO.,LTD.Industry (pharma, biotech, devices)
- Study start
- 4 Jul 2024 (actual)
- Primary completion
- 17 Mar 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Feasibility study of the DuoCor Ventricular Assist System as a treatment for advanced total heart failure patients.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DuoCor Ventricular Assist System | Experimental | Device: DuoCor Ventricular Assist System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients who require biventricular mechanical circulatory support, defined by either of the following criteria:
- Patient has signed the informed consent, has full understanding of procedures, and is committed to following study requirements.
Key exclusion criteria (8 listed)
- Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patient's health status.
- Technical obstacles which pose the implantation as unsuitable, obtaining the body type, body surface area, and anatomical conditions related to the planned implantation site, in the judgment of the experienced investigators.
- Pregnancy.
- Age > 75 years.
- Presence of an active, uncontrolled infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuoCor Ventricular Assist SystemThe DuoCor VAS is used to provide hemodynamic support by shareing some or all the workload of the left and right ventricles during the support period. | Device | DuoCor Ventricular Assist System |
Primary outcome
Composite of survival at 3 months post-implantation
Time frame: 3 months
Composite of survival to transplant, recovery (defined as complete/ partial removal or explantation of the DuoCor VAS due to cardiac recovery), or survival with the device at 3 months post-implantation
2 secondary outcomes
Hospital redmission rate
Time frame: 3 months
Adverse Events.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: Yes. At this moment the IPD is not yet available for access and will be updated when it is ready.
Related trials for Heart Failure
Active, not recruiting
Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)
Heart Failure, Congestive Heart Failure
Active, not recruiting
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
Heart Failure With Preserved Ejection Fraction, Concentric Hypertrophy
Recruiting
Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
HFrEF - Heart Failure With Reduced Ejection Fraction
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DuoCor Ventricular Assist System in people with 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 24 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of survival at 3 months post-implantation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2026; AzTrials last refreshed its copy on 29 Oct 2026.