NCT05928273已完成不适用
Corheart 6 Left Ventricular Assist System Long Term Follow-up Clinical Evaluation Plan
Shenzhen Core Medical Technology CO.,LTD.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年12月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Survival [ Time Frame: 6 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) when used for the treatment of advanced refractory heart failure.
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Patient or legal representative has signed Informed Consent Form (ICF)
- •BSA ≥ 1.0 m2
- •Females of child bearing age must agree to use adequate contraception
- •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)
- •LVEF ≤ 30%,and at least one of the following conditions occurs:
- •For those whose condition cannot be reversed or can't be removed by using intraaortic balloon pump (IABP), extracorporeal membrane oxygenator (ECMO) orother short-term mechanical circulation assistance;
- •Rely on continuous intravenous administration of one or more cardioactive drugs or positive inotropic drugs;
- •Meeting diagnostic criteria of cardiogenic shock: blood pressure < 90/60mmHg; Cardiac discharge index < 2.0; Pulmonary capillary wedge pressure > 18mmHg
排除标准
- •Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy,pericardial disease, amyloidosis or restrictive cardiomyopathy.
- •Active, uncontrolled infection confirmed by a combination of clinical symptoms and laboratory tests.
- •In the investigator's judgment, there are technical difficulties that lead to an unacceptable hig surgical risk.
- •The patient was intolerant to anticoagulant or antiplatelet therapy or was unable to receive other perioperative and postoperative treatments that the investigator deemed necessary based on the patient's health condition.
- •Patients require biventricular assist device support.
- •Pregnancies.
- •The patient had moderate to severe aortic insufficiency or a history of mechanical aortic valve implantation, but did not agree or could not be corrected by replacement or replacement of biological valve during LVAD implantation.
- •History of visceral organ transplantation.
- •Have uncorrected thrombocytopenia or severe coagulopathy, such as diffuse intravascular coagulation.
- •TBIL (total bilirubin) > 3.0 mg/dL and serum creatinine (SCr) > 3.0 mg/dL within 48 hours before surgery may require dialysis.
- •History of severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease or a diagnosis of primary pulmonary hypertension。
- •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 demonstrated that pulmonary vascular resistance did not respond to drug therapy: pulmonary vascular resistance greater than 8 wood units; The transpulmonary differential pressure exceeds 20mmHg.
- •Established and untreated abdominal or thoracic aortic aneurysm > 5cm in diameter.
- •Severe peripheral vascular disease with resting pain or extremity ulceration.
- •Patients with psychiatric disorders/disorders, irreversible cognitive impairment or psychosocial problems are at risk of failing to comply with research protocols and regulations governing the use of implantable LEFT ventricular assist systems or brain death from various causes.
- •Expect to live less than 1 year if you have a malignant tumor or other disease.
- •Patients participate in any other clinical trials that may influence the results of this study.
- •Other circumstances that are unforeseen and determined by the researcher to be unsuitable.
结局指标
主要结局
Survival [ Time Frame: 6 months ]
时间窗: 6 months
Patients survived with the device for at least 6 months without disabling stroke (disabling stroke disabling stroke defined as a mRS Score \> 3 at 60 days after stroke) and without reoperation (replacement or removal) due to device problems.
次要结局
- Functional Status - Six Minute Walk Test (6MWT)([ Time Frame: Baseline, Month 1, Month 3, Month 6 ])
- Kansas City Cardiomyopathy Questionnaire (KCCQ)(Baseline, Month 1, Month 3, Month 6)
- Quality of Life (EQ-5D-5L)(Baseline, Month 1, Month 3, Month 6)
- New York Heart Association (NYHA) Classification(Baseline, Month 1, Month 3, Month 6)
研究者
研究点 (1)
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