NCT07757451尚未招募不适用
A Prospective, Multicenter,Single-arm Study of DuoCor 2 Ventricular Assist System for the Treatment of Advanced Biventricular Heart Failure
Shenzhen Core Medical Technology CO.,LTD.1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2026年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Event-free survival rate at 6 months post-implantation
研究概览
简要总结
The objective of this clinical investigation is to evaluate the safety and efficacy of the DuoCor 2 Ventricular Assist System (DuoCor 2 VAS) in subjects with advanced biventricular heart failure requiring circulatory support.
Each subject receiving the DuoCor 2 VAS will be evaluated at 6 months (180 days) for primary and secondary endpoints with further follow-up assessments up to 2 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.18 years ≤ Age ≤ 75 years
- •2.INTERMACS Class 1-2
- •3.Patient is inotrope dependent, OR has a Cardiac Index (CI) < 2.2 L/min/m2, while not on inotropes
- •4. Patient has reduced exercise capacity due to cardiac factors with at least one of the following criteria:
- •Unable to exercise
- •6-minute walking test (6MWT) < 300 meters
- •5.Patient has right heart failure related symptoms such as lower limbs edema, jugular vein distension
- •6.Patient has advanced, irreversible biventricular heart failure and is deemed to be eligible for biventricular mechanical circulatory support by clinical expertise.
- •6a: advanced left heart failure
- •Left ventricular ejection fraction (LVEF) ≤ 30%;
- •Pulmonary capillary wedge pressure (PCWP) > 15mmHg.
- •6b: severe right heart failure despite guideline-directed medical therapy. This includes at least one evaluation index of right ventricular function and at least one evaluation index of volume load or structural abnormality:
- •Evaluation index of right ventricular function:
- •Right ventricular ejection fraction (RVEF)≤ 30%;
- •Right ventricular stroke work index (RVSWI)≤ 0.25 mmHg*L/m2;
- •Right ventricle fractional area change(RVFAC) < 30%;
- •Evaluation index of volume load or structural abnormality:
- •Central venous pressure (CVP)> 15 mmHg;
- •CVP to PCWP ratio> 0.63;
- •Moderate to severe tricuspid regurgitation;
- •Right ventricular (RV) to left ventricular (LV) end-diastolic diameter ratio> 0.72;
- •Tricuspid annular plane systolic excursion (TAPSE)≤ 14 mm;
- •Pulmonary artery pressure index (PAPi)<
- •7.Patient or its legal representative has signed the informed consent, has full understanding of procedures and the study, and is committed to following study requirements.
排除标准
- •1.Known intolerance to anticoagulant or antiplatelet therapies.
- •2.Etiology of heart failure due to restrictive or constrictive physiology (e.g., hypertrophic cardiomyopathy, cardiac amyloidosis /senile or other infiltrative heart disease)
- •3.Coagulopathy defined by platelets < 100*10^9/L or INR ≥ 1.5 not due to anticoagulant therapy.
- •4. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.
- •5. Presence of temporary mechanical circulatory support such as Impella (all types) or IABP with a duration greater than 21 days.
- •6. Presence of ECMO with a duration greater than 10 days.
- •7.Moderate to severe aortic valve regurgitation or pulmonary valve regurgitation, and refusal of bioprosthetic valve replacement.
- •8.Presence of mechanical aortic valve or pulmonary valve, and refusal of bioprosthetic valve replace.
- •9. Patient is implanted with durable mechanical circulatory support (LVAD or RVAD) and has refused to switch to the study device.
- •10. Patient experienced cerebrovascular accident (CVA) within 3 months of eligibility evaluation.
- •11. Presence of significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.
- •12. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
- •Total bilirubin > 3.0 mg/dL or cirrhosis confirmed by imaging or positive biopsy;
- •Glomerular filtration rate (GFR) < 30 mL/min/1.73 m2 or renal replacement therapy dependence;
- •History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, and FEV1 < 50% predicted.
- •13. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units.
- •14. Severe systemic light-chain amyloidosis.
- •15. Blood stream infection within 7 days. Positive blood cultures reflective of contaminants (e.g., Staphylococcus epidermidis) will not be considered an exclusion.
- •16. Sepsis
- •17. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) > 5 cm in diameter.
- •18.Any condition other than HF that could limit survival to less than 24 months.
- •19.Positive pregnancy test if of childbearing potential, lactating mothers.
- •20.Presence of psychiatric disorders, irreversible cognitive impairment, or psychosocial issues that may compromise their ability to comply with the study protocol and management requirements for implantable ventricular assist devices, or brain death due to any cause.
- •21. Participation in any other clinical investigation that is likely to confound study results or affect the study.
- •22.Ineligibly based on physician's judgement due to other severe conditions or other conditions which can interfere with subject's compliance to the study.
研究组 & 干预措施
DuoCor 2 VAS
Experimental
The DuoCor 2 Ventricular Assist System (DuoCor 2 VAS) to be used on patients with advanced biventricular heart failure
干预措施: DuoCor 2 Ventricular Assist System (DuoCor 2 VAS) (Device)
结局指标
主要结局
Event-free survival rate at 6 months post-implantation
时间窗: 6 months
Event-free survival rate at 6 months post-implantation. Events are defined as all-cause death, ECMO implantation, and IABP implantation.
次要结局
- Function Status as measured by Six Minute Walk Test (6MWT)(Baseline, Month 6, Month 12, Month 24)
- Functional status as measured by the New York Heart Association (NYHA) Classification(Baseline, Month 6, Month 12, Month 24)
- Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L)(Baseline, Month 6, Month 12, Month 24)
- Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)(Baseline, Month 6, Month 12, Month 24)
- Unplanned Rehospitalization(Month 3, Month 6, Month 12, Month18, Month 24)
- Event-free survival rate within 24 months post-implantation.(Week 1, Month 1, Month 3, Month 6, Month 12, Month 18, Month 24)
- Adverse Events(Week 1, Month 1, Month 3, Month 6, Month 12, Month 18, Month 24)
研究者
研究点 (1)
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