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

Shenzhen Core Medical Technology

Status

Completed

Conditions

End-stage Heart Failure

Treatments

Device: Corheart 6 Left Ventricular Assist System

Study type

Interventional

Funder types

Industry

Identifiers

NCT05353816

COREMED_LVAS

Details and patient eligibility

About

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.

Full 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 providing short-term and long-term mechanical circulatory support for patients with end-stage heart failure. This prospective, multi-center, and single-arm trial evaluates the safety and effectiveness of the device in treating patients with end-stage heart failure. 50 patients from 12 investigational sites will be enrolled for Corheart 6 VAS implantation and followed for 3 months post-implantation. The primary study endpoint is the success rate of device implantation at 3 months post-implantation. All adverse events will be adjudicated by an independent Clinical Events Committee (CEC).

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.