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Clinical Trials in China / NCT05353816
Active, not recruiting Not applicable

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

NCT05353816 · tracked via the Priya Life Science China tracker
Sponsor
Shenzhen Core Medical Technology CO.,LTD.
Phase
Not applicable
Started
2022-01-26
Last updated
2026-02-02

Condition(s) studied

End-stage Heart Failure

Investigational drug(s) / intervention(s)

Corheart 6 Left Ventricular Assist System

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)

Trial sites (11)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT05353816 on ClinicalTrials.gov ↗ ← All trials in China