Clinical trial NCT05353816: Corheart 6 Left Ventricular Assist System Prospective, Multicenter, Single-arm Clinical Evaluation Trial
Official title: Corheart 6 Left Ventricular Assist System Prospective, Multicenter, Single-arm Clinical Evaluation Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-stage Heart Failure
Keywords: End-stage Heart Failure
Ventricular Assist System
Mechanical Circulatory Support
Lead sponsor: Shenzhen Core Medical Technology CO.,LTD.
Sponsor class: INDUSTRY
First posted: 2022-04-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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).

Eligibility criteria: 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 outcomes:
measure: The success rate of device implantation at 3 months.
timeFrame: Up to 3 months post-implantation.
Secondary outcomes:
measure: Functional status as measured by the New York Heart Association (NYHA) Classification
timeFrame: Baseline, at hospital discharge (assessed up to 5 days), and at 3 months post-implantation.
measure: Quality of Life as measured by the EuroQoL-5D-3L (EQ-5D-3L) questionnaire
timeFrame: Baseline, at hospital discharge (assessed up to 5 days), and at 3 months post-implantation.
measure: Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ-23).
timeFrame: Baseline, at hospital discharge (assessed up to 5 days), and at 3 months post-implantation.
measure: Functional status as measured by the Six Minute Walk Test (6MWT)
timeFrame: Baseline, at hospital discharge (assessed up to 5 days), and at 3 months post-implantation.
measure: Stroke severity as assessed with the National Institutes of Health Stroke Scale (NIHSS) score.
timeFrame: From baseline to 3 months post-implantation.
measure: Stroke severity as assessed by the modified Rankin Scale (mRS) score
timeFrame: From baseline to 3 months post-implantation.
measure: Adverse Events
timeFrame: From baseline to 3 months post-implantation.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Sciences(CAMS)
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: The Second XIANGYA Hospital Of Central South University
state: Hunan
city: Zhengzhou
country: China
facility: Fuwai Central China Cardiovascular Hospital
state: Hunan
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Xi'an
country: China
facility: Xijing Hospital of Air Force Medical University
state: Shanxi
city: Xinjiang
country: China
facility: People's Hospital of Xinjiang Uygur Autonomous Region
state: Xinjiang
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Shengshou Hu
role: PRINCIPAL_INVESTIGATOR
References: