New heart pump trial offers hope for End-Stage heart failure patients
NCT ID NCT05353816
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
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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
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50 people
The number who actually took part.
- Started
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Jan 2022
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Fujian Medical University Union Hospital
Fuzhou, Fujian, China
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Fuwai Central China Cardiovascular Hospital
Zhengzhou, Hunan, China
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Fuwai Hospital, Chinese Academy of Medical Sciences(CAMS)
Beijing, Beijing Municipality, China
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Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
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Nanjing First Hospital
Nanjing, Jiangsu, China
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People's Hospital of Xinjiang Uygur Autonomous Region
Xinjiang, Xinjiang, China
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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
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The Second XIANGYA Hospital Of Central South University
Changsha, Hunan, China
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
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Xijing Hospital of Air Force Medical University
Xi’an, Shanxi, China
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Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Heart pump vs. pills: which keeps End-Stage heart failure patients alive longer?
- Could a simple pump flow measure predict organ health in heart device patients?
- New study aims to simplify heart monitoring for pump patients
- Heart pump could outperform drugs in advanced heart failure
- Heart Pump's impact on failing hearts to be measured in new study