Status:
COMPLETED
Corheart 6 Left Ventricular Assist System Prospective, Multicenter, Single-arm Clinical Evaluation Trial
Lead Sponsor:
Shenzhen Core Medical Technology CO.,LTD.
Conditions:
End-stage Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
The Corheart 6 Left Ventricular Assist System (also called "the Corheart 6 LVAS", or "the Corheart 6") is developed and manufactured by Shenzhen Core Medical Technology Co., Ltd. It is indicated for p...
Eligibility Criteria
Inclusion
- (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
- (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.
Key Trial Info
Start Date :
January 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05353816
Start Date
January 26 2022
End Date
October 8 2022
Last Update
March 15 2024
Active Locations (11)
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1
Fuwai Hospital, Chinese Academy of Medical Sciences(CAMS)
Beijing, Beijing Municipality, China
2
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
3
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
4
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China