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End-stage Heart FailureNCT05353816

Corheart 6 Left Ventricular Assist System Prospective, Multicenter, Single-arm Clinical Evaluation Trial

A study testing Corheart 6 Left Ventricular Assist System in people with End-stage Heart Failure, run by Shenzhen Core Medical Technology CO.,LTD. at 11 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is to evaluate the safety and effectiveness of the Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) used for the treatment of end-stage heart failure. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
End-stage Heart Failure
What is being tested?
Corheart 6 Left Ventricular Assist System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
11 sitesChina
Study dates
26 Jan 2022to 1 Oct 2027
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (1) Age ≥ 18 years.
  • (2) The patient or legal representative has signed the Informed Consent Form (ICF).
  • (3) Body Surface Area (BSA) ≥ 1.0 m^2.
  • (4) Females of childbearing age must agree to use adequate contraception.
  • (5) Patients with NYHA Class IV heart failure symptoms who have failed to be reversed by previous standardized oral treatment with anti-heart failure drugs (ACEI, beta-blockers, and diuretics).
  • (6) Left Ventricular Ejection Fraction (LVEF) ≤ 30%, and at least one of the following conditions occurs:
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  • a. Fail to be reversed by or be weaned from intra-aortic balloon pump (IABP), extracorporeal membrane oxygenator (ECMO), or other short-term mechanical circulatory support;
  • b. Rely on continuous intravenous administration of one or more vasoactive or inotropic drugs;
  • c. Meeting the diagnostic criteria of cardiogenic shock: blood pressure < 90/60mmHg, cardiac index < 2.0 L/min/m^2, and pulmonary capillary wedge pressure > 18mmHg.

Who cannot join

  • (1) Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy pericardial disease, amyloidosis, or restrictive cardiomyopathy.
  • (2) Presence of an active, uncontrolled infection confirmed by a combination of clinical symptoms and laboratory tests.
  • (3) Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.
  • (4) Intolerance to anticoagulant or antiplatelet therapies or any other peri/postoperative therapy the investigator will require based on the patient's health status.
  • (5) Patients require bi-ventricular assist device support.
  • (6) Pregnancy.
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  • (7) Presence of moderate to severe aortic insufficiency or a history of the mechanical aortic valve that will not be converted to a bioprosthesis or oversewn at the time of implantation.
  • (8) History of any organ transplantation.
  • (9) Presence of uncorrected thrombocytopenia or severe coagulopathy, such as diffuse intravascular coagulation.
  • (10) TBIL (total bilirubin) > 3.0 mg/dL, serum creatinine (SCr) > 3.0 mg/dL within 48 hours prior to LVAD implantation surgery or may require dialysis.
  • (11) History of severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease or a diagnosis of primary pulmonary hypertension.
  • (12) Pulmonary embolism and pulmonary artery systolic blood pressure exceeding 60mmHg within 3 weeks prior to enrollment combined with at least one of the following 2 parameters demonstrating that pulmonary vascular resistance did not respond to drug therapy: Pulmonary vascular resistance greater than 8 wood units; The transpulmonary differential pressure exceeds 20mmHg.
  • (13) Established and untreated abdominal or thoracic aortic aneurysm > 5cm in diameter.
  • (14) Presence of severe peripheral vascular disease with resting pain or extremity ulceration.
  • (15) Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and Left Ventricular Assist System management, or brain death from various causes.
  • (16) Expect to live less than 1 year due to malignant tumor or other diseases.
  • (17) Participation in any other clinical trials that may influence the results of this study.
  • (18) Other circumstances that are unforeseen and determined by the researcher to be unsuitable.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

China11 sites

  • Fuwai Hospital, Chinese Academy of Medical Sciences(CAMS)

    Beijing, Beijing Municipality

  • The Second XIANGYA Hospital Of Central South University

    Changsha, Hunan

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

  • Nanjing First Hospital

    Nanjing, Jiangsu

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

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

    Wuhan, Hubei

  • Xijing Hospital of Air Force Medical University

    Xi’an, Shanxi

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Xinjiang, Xinjiang

  • Fuwai Central China Cardiovascular Hospital

    Zhengzhou, Hunan

Other trials in China

About this study

This study is to evaluate the safety and effectiveness of the Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) used for the treatment of end-stage heart failure.

Read the detailed description

The Corheart 6 Left Ventricular Assist System (also called "the Corheart 6 LVAS", or "the Corheart 6") is developed and manufactured by Shenzhen Core Medical Technology Co., Ltd. It is indicated for providing short-term and long-term mechanical circulatory support for patients with end-stage heart failure. This prospective, multi-center, and single-arm trial evaluates the safety and effectiveness of the device in treating patients with end-stage heart failure. 50 patients from 12 investigational sites will be enrolled for Corheart 6 VAS implantation and followed for 3 months post-implantation. Following the initial 3-month follow-up, the study was extended to assess the primary endpoint of event-free survival at 24 months, with further follow-up to 5 years to evaluate long-term outcomes. The primary endpoint include the success rate of device implantation at 3 months and event-free survival at 24 months post-implantation. All adverse events will be adjudicated by an independent Clinical Events Committee (CEC).

Being tested
Corheart 6 Left Ventricular Assist System
Keywords
End-stage Heart Failure, Ventricular Assist System, Mechanical Circulatory Support

What participants receive

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

  • Corheart 6 Left Ventricular Assist SystemDevice

    Implantation of the Corheart 6 Left Ventricular Assist Device for mechanical circulatory support.

Study groups in NCT05353816
Study groupRoleWhat they receive
Corheart 6 LVASExperimentalCorheart 6 Left Ventricular Assist System (Corheart 6 LVAS) to be used on patients with end-stage heart failure.
Receives: Device: Corheart 6 Left Ventricular Assist System

What is being measured

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

  1. The success rate of device implantation at 3 months.

    The success rate of device implantation at 3 months post-implantation.

    Device implantation success will be met when a patient is still alive on device support, free of disabling stroke (modified Rankin Scale (mRS) > 3), and does not have the device replaced or removed due to device deficiency at 3 months post-implantation.

    The modified Rankin Scale is a tool used to assess functional disability or dependence in daily activities following a stroke or other neurological condition. It ranges from 0 (No observed neurological symptoms) to 6 (dead). Higher scores indicate more severe functional impairment.

    Measured: Up to 3 months post-implantation.

  2. The event-free survival at 24 months post-implantation.

    Survival at 24 months post-implantation free of disabling stroke (mRS >3) or reoperation for device replacement. Subjects who undergo heart transplantation or device explantation due to myocardial recovery are considered to have met the primary endpoint.

    Measured: Up to 24 months post-implantation

Secondary outcomes (7)

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

    The NYHA (New York Heart Association) Functional Classification is a tool used to assess the severity of heart failure symptoms. It categorizes patients into one of four classes based on their level of activity limitation and symptoms. Class I represents no limitation of physical activity, while Class IV indicates severe limitations even at rest.

    Measured: Baseline, at hospital discharge (within 5 days), and at 3, 6, 12, 24 and 60 months post-implantation.

  2. Quality of Life as measured by the EuroQoL-5D-3L (EQ-5D-3L) questionnaire

    The EQ-5D-3L assesses health-related quality of life across five dimensions with three severity levels each. The scores from the 5 dimensions are summed for the total score which ranges from 5 to 15 with higher scores indicating more problems and a worse quality of life.

    Measured: Baseline, at hospital discharge (within 5 days), and at 3, 6, 12, 24 and 60 months post-implantation.

  3. Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ-23).

    The Kansas City Cardiomyopathy Questionnaire (KCCQ-3) evaluates heart failure patients' health status, including symptoms, physical limitations, social limitations, self-efficacy, and quality of life. Scores range from 0 to 100, with higher scores indicating better health-related quality of life.

    Measured: Baseline, at hospital discharge (within 5 days), and at 3, 6, 12, 24 and 60 months post-implantation.

  4. Functional status as measured by the Six Minute Walk Test (6MWT)

    The 6-Minute Walk Test (6MWT) assesses functional capacity and endurance by measuring the distance walked in six minutes. Results vary based on age, gender, and disease severity. Generally, greater distances indicate better functional capacity and endurance.

    Measured: Baseline, at hospital discharge (within 5 days), and at 3, 6, 12, 24 and 60 months post-implantation.

  5. Stroke severity as assessed with the National Institutes of Health Stroke Scale (NIHSS) score.

    The National Institutes of Health Stroke Scale measures stroke-related neurological deficits across various domains. Scores range from 0 to 42, with higher scores indicating more severe neurological impairment. Lower scores correlate with better neurological function.

    Measured: From baseline to 60 months post-implantation.

  6. Stroke severity as assessed by the modified Rankin Scale (mRS) score

    The modified Rankin Scale is a tool used to assess functional disability or dependence in daily activities following a stroke or other neurological condition. It ranges from 0 (No observed neurological symptoms) to 6 (dead). Higher scores indicate more severe functional impairment.

    Measured: From baseline to 60 months post-implantation.

  7. Adverse Events

    Frequency and incidence of all anticipated adverse events.

    Measured: From baseline to 60 months post-implantation.

Timeline

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

  1. First posted29 Apr 2022
  2. Study start26 Jan 2022
  3. Primary completion30 Sep 2024
  4. Study completion1 Oct 2027 (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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05353816
Sponsor's protocol ID
COREMED_LVAS
Status last verified
Aug 2025
First submitted
26 Apr 2022
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: At this moment the IPD is not yet available for access and will be updated when it is ready.

Publications

  • Wang X, Chen H, Du J, Zhou X, Zou L, Huang J, Chen L, Cheng Z, Dong N, Chen X, Liu J, Yang Y, Wang C, Yang Y, Shen Z, Wang H, Hu S. A novel magnetically levitated intrapericardial left ventricular assist system in advanced heart failure-2-year results from a prospective, multi-centre study. Eur J Cardiothorac Surg. 2026 Jan 9:ezag014. doi: 10.1093/ejcts/ezag014. Online ahead of print.

    PubMed 41512307

Questions about this trial

What is this clinical trial studying?

A study testing Corheart 6 Left Ventricular Assist System in people with End-stage Heart Failure, run by Shenzhen Core Medical Technology CO.,LTD. at 11 sites 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 9 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites 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?

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?

The success rate of device implantation at 3 months. (time frame: Up to 3 months post-implantation.). The study lists 2 primary outcomes in all. 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 NCT05353816, which also lists 1 linked publication.

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 2 Feb 2026.

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