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Heart FailureNCT07094919

Corheart 6: Long-term Cohort Study

A study testing Corheart 6 left ventricular assist system in people with Heart Failure, run by China National Center for Cardiovascular Diseases at 8 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to evaluate the long-term effectiveness and safety of Corheart 6 left ventricular assist system as a treatment for patients with advanced left heart failure. The patients who have received the Corheart 6 treatment since October 2021, or who are planned to received it, will be enrolled until the target… 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?
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
160 participants
Where
8 sitesChina
Study dates
12 Dec 2021to 30 Sep 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years.
  • Subject who have undergone Corheart 6 implantation on or after October 1, 2021.
  • Body Surface Area (BSA) > 1.0 m2.
  • Women of childbearing potential must use agree to use a effective method of contraception for the duration of the study.
  • Diagnosis of NYHA Class IV heart failure, refractory to optimal guideline-directed medical therapy (GDMT) (e.g., ACE inhibitors, β-blockers, and diuretics).
  • Left Ventricular Ejection Fraction (LVEF) < 30%, with at least one of the following conditions:
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  • Dependence on an intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO), or other short-term mechanical circulatory support with an inability to be weaned.
  • Dependence on continuous intravenous inotropic support.
  • Meets the diagnostic criteria for cardiogenic shock: blood pressure < 90/60 mmHg, cardiac index < 2.0, pulmonary capillary wedge pressure > 18 mmHg
  • Subject or their legally authorized representative agrees to participate in the study and signs the informed consent form.

Who cannot join

  • Heart failure caused by unresolved thyroid disease, hypertrophic obstructive cardiomyopathy, pericardial disease, or related conditions.
  • Presence of active, uncontrolled infection confirmed through clinical symptoms and laboratory tests.
  • Based on the investigator's judgment, presence of technical difficulties that would lead to unacceptable surgical risk.
  • Subject is intolerant to anticoagulation or antiplatelet therapy, or cannot receive other perioperative and postoperative treatments deemed necessary by the investigator based on the patient's health condition.
  • Require biventricular assist device support.
  • Pregnancy.
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  • Presence of moderate to severe aortic regurgitation or a history of mechanical aortic valve implantation but refuse or is unable to converted to a bioprosthesis or oversewn at the time of LVAD implant.
  • History of any organ transplant.
  • Presence of unresolved thrombocytopenia or severe coagulopathy, such as disseminated intravascular coagulation (DIC).
  • Preoperative total bilirubin (TBIL) > 3.0 mg/dL, serum creatinine (SCr) > 3.0 mg/dL, or requirement for dialysis within 48 hours prior to surgery.
  • History of severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, or diagnosed primary pulmonary hypertension.
  • Presence of pulmonary embolism within 3 weeks prior to enrollment.
  • Pulmonary artery systolic pressure greater than 60 mmHg and meet at least one of the criteria which prove the pulmonary vessels is unresponsive to pharmacologic intervention: a. most recent pulmonary vascular resistance (PVR) ≥ 8 Woods; b. transpulmonary pressure > 20mmHg.
  • History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) > 5 cm in diameter.
  • Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.
  • Mental illness/disorder, irreversible cognitive dysfunction, or psychosocial issues that may prevent the patient from adhering to the study protocol and the management of the implanted left ventricular assist device, or any condition leading to brain death.
  • Presence cancer or other diseases that could limit survival to less than 24 months.
  • Participation in any other clinical investigation that is likely to confound study results or affect the study.
  • Unforeseen circumstances that the investigator determines to be unsuitable for the study.

Trial locations and contacts

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

Xianqiang Wang contact

+86 13331006960

qiangxianwang@163.com

8 sites in 1 country

China8 sites, 8 recruiting

  • Fuwai Hospital

    Beijing

    Xianqiang Wang, qiangxianwang@163.com

    Recruiting

  • Nanjing First Hospital

    Nanjing, Jiangsu

    Xin Chen, stevecx@njmu.edu.cn

    Recruiting

  • the First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu

    Yongfeng Shao, yongfeng_shao@163.com

    Recruiting

  • Zhongshan Hospital Fudan University

    Shanghai

    Chunsheng Wang, wang.chunsheng@zs-hospital.sh.cn

    Recruiting

  • Fuwai Hospital Chinese Academy of Medical Sciences

    Shenzhen, Guangdong

    Haibo Chen, +86 18910171249, chenhaibo@fuwai.com

    Recruiting

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

    Wuhan, Hubei

    Nianguo Dong, dongnianguo@hotmail.com

    Recruiting

  • Wuhan asia heart hospital

    Wuhan, Hubei

    Zhengdong Hua

    Recruiting

  • the 7Th People'S Hospital of Zhengzhou

    Zhengzhou, Henan

    Xiangli Zhang

    Recruiting

Other trials in China

About this study

Official title: An Cohort Study of Corheart 6 Left Ventricular Assist System for the Treatment of Patients With Advanced Left Heart Failure

This study aims to evaluate the long-term effectiveness and safety of Corheart 6 left ventricular assist system as a treatment for patients with advanced left heart failure. The patients who have received the Corheart 6 treatment since October 2021, or who are planned to received it, will be enrolled until the target sample size meets statistical requirements.

Data collected will include survival status, cardiac function status, quality of life, laboratory parameters and adverse events. The primary endpoint are the composite of survival at 6 months and, separately, at 24 months, defined as survival with device support, bridge to heart transplant and device explantation due to cardiac recovery, without disabling stroke (mRS > 3) or device replacement. Data collection will adhere to the follow-up schedule specified in the protocol.

Conditions
Heart Failure
Being tested
Corheart 6 left ventricular assist system
Keywords
advanced heart failure, Corheart 6
Medical subject headings
Heart Failure

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

    Corheart 6 left ventricular assist system provides circulatory support for patients with advanced left heart failure.

Study groups in NCT07094919
Study groupRoleWhat they receive
Corheart 6 Left Ventricular Assist SystemExperimentalSubjects with advanced left heart failure despite receiving optimal medical therapy, as per current heart failure management guidelines
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. Composite survival rate at 6 months.

    The composite survival is defined as one of the following criteria, without disabling stroke (modified Rankin Score >3 ), device replacement due to device malfunction, or urgent heart transplant due to device malfunction:

    • heart transplant;
    • explantation for cardiac recovery;
    • survival with device support.

    Measured: 6 months

  2. Composite survival rate at 24 months

    Measured: 24 months

Secondary outcomes (7)

  1. Composite survival rate at 5 years post device implantation

    Measured: 5 years

  2. NYHA Functional Class

    Measured: Baseline, 6 months, 24 months, and 5 years post-implantation

  3. 6-minute walk test distance

    Measured: Baseline, 6 months, 24 months, and 5 years post-implantation

  4. EuroQol-5D

    Measured: Baseline, 6 months, 24 months, 5 years post-implantation

  5. Adverse Events

    Measured: Up to 5-year post-implantaiton

  6. Reoperation

    Measured: Up to 5-year post-implantation

  7. Rehospitalization

    Measured: Up to 5-year 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 posted31 Jul 2025
  2. Study start12 Dec 2021
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 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
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07094919
Sponsor's protocol ID
2025-ZX036
Status last verified
Jul 2025
First submitted
28 Jul 2025
Last updated
31 Jul 2025
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.

Questions about this trial

What is this clinical trial studying?

A study testing Corheart 6 left ventricular assist system in people with Heart Failure, run by China National Center for Cardiovascular Diseases at 8 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 10 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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?

Contact Xianqiang Wang (+86 13331006960, qiangxianwang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite survival rate at 6 months. (time frame: 6 months). 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 NCT07094919.

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 31 Jul 2025.

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