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New heart pump trial offers hope for End-Stage heart failure patients

NCT ID NCT05353816

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial is testing a new mechanical heart pump called the Corheart 6 in 50 people with end-stage heart failure. The pump is implanted to help the heart circulate blood. Researchers are checking if the device works safely and effectively at 3 months and 2 years after implantation, focusing on survival without major stroke or device problems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Corheart 6 Left Ventricular Assist Device (a mechanical heart pump)
What this could lead to
If successful, this device could offer a reliable, long-term option to keep people with severe heart failure alive and active while they wait for a transplant or as a permanent solution.
What could go wrong
This is an early-stage trial with only 50 participants, so results may not apply to everyone. Risks include stroke, device failure, or infection, and the device requires ongoing medical management.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

50 people

The number who actually took part.

Started

Jan 2022

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * (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: * 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. Exclusion Criteria: * (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. * (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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, China

  • Fuwai Central China Cardiovascular Hospital

    Zhengzhou, Hunan, China

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

    Beijing, Beijing Municipality, China

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, China

  • Nanjing First Hospital

    Nanjing, Jiangsu, China

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Xinjiang, Xinjiang, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, China

  • The Second XIANGYA Hospital Of Central South University

    Changsha, Hunan, China

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

    Wuhan, Hubei, China

  • Xijing Hospital of Air Force Medical University

    Xi’an, Shanxi, China

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.