Corheart 6 Left Ventricular Assist System Prospective, Multicenter, Single-arm Clinical Evaluation Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 11
- 主要终点
- The success rate of device implantation at 3 months.
研究概览
简要总结
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.
详细描述
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. Following the initial 3-month follow-up, the study was extended to assess the primary endpoint of event-free survival at 24 months, with further follow-up to 5 years to evaluate long-term outcomes. The primary endpoint include the success rate of device implantation at 3 months and event-free survival at 24 months post-implantation. All adverse events will be adjudicated by an independent Clinical Events Committee (CEC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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^
- •(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.
排除标准
- •(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.
研究组 & 干预措施
Corheart 6 LVAS
Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) to be used on patients with end-stage heart failure.
干预措施: Corheart 6 Left Ventricular Assist System (Device)
结局指标
主要结局
The success rate of device implantation at 3 months.
时间窗: 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.
时间窗: 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.
次要结局
- Functional status as measured by the New York Heart Association (NYHA) Classification(Baseline, at hospital discharge (within 5 days), and at 3, 6, 12, 24 and 60 months post-implantation.)
- Quality of Life as measured by the EuroQoL-5D-3L (EQ-5D-3L) questionnaire(Baseline, at hospital discharge (within 5 days), and at 3, 6, 12, 24 and 60 months post-implantation.)
- Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ-23).(Baseline, at hospital discharge (within 5 days), and at 3, 6, 12, 24 and 60 months post-implantation.)
- Functional status as measured by the Six Minute Walk Test (6MWT)(Baseline, at hospital discharge (within 5 days), and at 3, 6, 12, 24 and 60 months post-implantation.)
- Stroke severity as assessed with the National Institutes of Health Stroke Scale (NIHSS) score.(From baseline to 60 months post-implantation.)
- Stroke severity as assessed by the modified Rankin Scale (mRS) score(From baseline to 60 months post-implantation.)
- Adverse Events(From baseline to 60 months post-implantation.)