Corheart 6 Left Ventricular Assist System: Implantation of the Corheart 6 Left Ventricular Assist Device for mechanical circulatory support.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
The success rate of device implantation at 3 months. — Up to 3 months post-implantation. 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.
The event-free survival at 24 months post-implantation. — Up to 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.
Trial sites (11)
Facility
City
Region
Status
Fuwai Hospital, Chinese Academy of Medical Sciences(CAMS)
Beijing
Beijing Municipality
Fujian Medical University Union Hospital
Fuzhou
Fujian
Guangdong Provincial People's Hospital
Guangzhou
Guangdong
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Hubei
The Second XIANGYA Hospital Of Central South University
Changsha
Hunan
Fuwai Central China Cardiovascular Hospital
Zhengzhou
Hunan
Nanjing First Hospital
Nanjing
Jiangsu
The First Affiliated Hospital of Soochow University
Suzhou
Jiangsu
Zhongshan Hospital, Fudan University
Shanghai
Shanghai Municipality
Xijing Hospital of Air Force Medical University
Xi’an
Shanxi
People's Hospital of Xinjiang Uygur Autonomous Region
Xinjiang
Xinjiang
More Shenzhen Core Medical Technology CO.,LTD. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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