NCT06267612尚未招募不适用
Long-term Follow-up Study of Corheart 6 Left Ventricular Assist System as Treatment of Patients With Advanced Heart Failure
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Device implantaion success rate at 24 months post-implantation
研究概览
简要总结
The purpose of this clinical study is to explore the long-term efficacy and safety of the Corheart 6 Left Ventricular Assist System (LVAS) as a treatment for patients with advanced heart failure.
The study will be a single-arm, prospective, single-center, non-blinded, and non-randomized study with a follow-up duration of five years.
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
- •Age ≥ 18 years.
- •The patient or legal representative is willing to participate in the study and offers informed consent.
- •Body surface area (BSA) ≥ 1.0 m^
- •Females of childbearing age must agree to use adequate contraception.
- •Patients with NYHA Class IV heart failure symptoms who have failed to be reversed by standardized treatment with oral anti-heart failure drugs.
- •Left Ventricular Ejection Fraction (LVEF) ≤ 35%, 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 (optional), and pulmonary capillary wedge pressure > 18mmHg (optional).
排除标准
- •Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive hypertrophic cardiomyopathy, or pericardial disease.
- •Presence of an active, uncontrolled infection confirmed by a combination of clinical symptoms and laboratory tests.
- •Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.
- •Intolerance to anticoagulant or antiplatelet therapies or any other peri/postoperative therapy the investigator will require based on the patient's health status.
- •Patients require bi-ventricular assist device support.
- •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.
- •History of any organ transplantation.
- •Presence of uncorrected thrombocytopenia or severe coagulopathy, such as diffuse intravascular coagulation.
- •TBIL (total bilirubin) > 3.0 mg/dL within 48 hours prior to implantation.
- •Serum creatinine (SCr) > 3.0 mg/dL within 48 hours prior to implantation or may require dialysis.
- •Presence of severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease or a diagnosis of primary pulmonary hypertension.
- •Presence of pulmonary embolism within 3 weeks prior to implantation.
- •Pulmonary artery systolic pressure exceeds 60mmHg, combined with at least one of the following 2 parameters demonstrating that pulmonary vascular resistance did not respond to drug therapy:
- •a. Pulmonary vascular resistance greater than 8 wood units.
- •b. The transpulmonary differential pressure exceeds 20mmHg.
- •Established and untreated abdominal or thoracic aortic aneurysm > 5cm in diameter.
- •Presence of severe peripheral vascular disease with resting pain or extremity ulceration.
- •Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management, or brain death from various causes.
- •History of documented disabling stroke within 90 days prior to implantation, a history of cerebrovascular disease, or the presence of uncorrected severe bilateral carotid artery stenosis.
- •History of acute myocardial infarction within 60 days prior to implantation, judged by the investigator to have a risk of myocardial rupture or other surgical high-risk difficult-to-control bleeding, etc.
- •Expected lifetime of less than 1 year due to malignant tumor or other disease.
- •Participation in any other clinical study that may influence the results of this study.
- •Other circumstances that are unforeseen and determined by the researcher to be unsuitable.
研究组 & 干预措施
Corheart 6 LVAS
Experimental
Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) to be used on patients with advanced heart failure.
干预措施: Corheart 6 Left Ventricular Assist System (Device)
结局指标
主要结局
Device implantaion success rate at 24 months post-implantation
时间窗: Up to 24 months post-implantation
Device implantation success is defined as: * A. Electively transplanted or explanted prior to 24 months or * B. Alive at 24 months, and * I. Have not experienced a stroke with a modified Rankin Score \> 3, and * II. Have not received a device replacement or exchange due to a device malfunction, and * III. Have not received an urgent transplant due to a device malfunction.
次要结局
- Adverse events(As they occur, from baseline to 24 months post-implantaion)
- Device-related re-operations(As they occur, from baseline to 24 months post-implantaion)
- Functional status as measured by the New York Heart Association (NYHA) Classification(Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation)
- Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23)(Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation)
- Functional status as measured by the Six Minute Walk Test (6MWT)(Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation)
- Stroke severity as assessed by the modified Rankin Scale (mRS) score(Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation, and as a stoke event occurs, from baseline to 24 months post-implantation)
- Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L) questionnaire(Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation)
- Device-related re-hospitalizations(As they occur, from initial hospital discharge to 24 months post-implantation)
- Stroke severity as assessed with the National Institutes of Health Stroke Scale (NIHSS) score(Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation, and as a stoke event occurs, from baseline to 24 months post-implantation)
- Overall survival(Up to 60 months post-implantation)
研究者
Zhibing Qiu
Professor
Nanjing First Hospital, Nanjing Medical University
研究点 (1)
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