NCT05876000招募中不适用
Prospective Multi-Center Single-Arm Study for Evaluating the Corheart 6 Left Ventricular Assist System
Shenzhen Core Medical Technology CO.,LTD.11 个研究点 分布在 3 个国家目标入组 53 人开始时间: 2024年5月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 53
- 试验地点
- 11
- 主要终点
- Composite of surivival
研究概览
简要总结
The primary objective of this study is to evaluate the safety and effectiveness of the Corheart 6 LVAS when used for the treatment of advanced left ventricular heart failure in a European population at 6 months post-implantation.
The secondary objective is to assess the long-term safety and effectiveness of Corheart 6 LVAS treatment.
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. Age ≥ 18 years and ≤ 75 years
- •2. The patient has signed an Informed Consent Form
- •3. Body Surface Area (BSA) ≥ 1.2 m^2
- •4. New York Heart Association (NYHA) Class IV
- •5. Left Ventricular Ejection Fraction (LVEF) ≤ 25%
- •6. Despite the optimal medical management based on current guidelines, the patient must also meet one or more of the following:
- •a. Unable to exercise for HF,
- •if able to perform cardiopulmonary testing, with peak VO2 <12 mL/kg/min and/or < 50% predicted value;
- •b. Progressive end-organ dysfunction (worsening renal and/or hepatic function, type II pulmonary hypertension, cardiac cachexia) due to reduced perfusion and not to inadequately low ventricular filling pressure (PCWP > 20 mmHg and SBP < 90 mmHg or CI < 2.0 L/min/m2).
- •c. Impella or IABP assisted;
- •d. Inotrope dependent/unable to wean from inotropes.
排除标准
- •1. Heart failure who can be treated with other therapy options (e.g. CRT, CRT-D, etc.)
- •2. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status.
- •3. Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia type II.
- •4. Platelet count < 100,000 x 10^3/L (< 100,000/ml).
- •5. Psychiatric disease/ disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and ventricular assist system management.
- •6. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.
- •7. Presence of an active, uncontrolled infection.
- •8. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
- •a. Total bilirubin > 51.3 μmol/L (3.0 mg/dl), ischemic hepatitis, or biopsy proven liver cirrhosis, or clinically Child-Pugh B and C score.
- •b. History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, or FEV1 < 50% predicted.
- •c. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention.
- •d. History of stroke within 180 days prior to enrollment, or a history of cerebrovascular disease with symptomatic (> 70%) carotid artery stenosis
- •e. Serum creatinine ≥ 265 μmol/L (3.0mg/dl) or requiring dialysis.
- •f. Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.
- •9. Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive/ restrictive cardiomyopathy, pericardial disease, amyloidosis or giant cell myocarditis.
- •10. Uncorrected moderate to severe aortic insufficiency without plans for correction during pump implant.
- •11. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) > 5 cm in diameter.
- •12. Uncontrollable ventricular tachyarrythmias/ ventricular fibrillation (VF).
- •13. STEMI <2 weeks before planned implantation.
- •14. Right ventricular failure as defined by one or more of the following:
- •a. severe depressed RV function in echocardiography
- •b. TAPSE < 1.0 cm
- •c. CVP/PCWP ratio > 0.63
- •15. Planned Bi-VAD support prior to enrollment.
- •16. Cardiac arrest with a history of resuscitation 1-month before inclusion, without full restoration of cognitive function.
- •17. History of any organ transplant.
- •18. Pre albumin < 150 mg/L, or Albumin < 30g/L (3 g/dL).
- •19. Any condition other than HF that could limit survival to less than 24 months.
- •20. Positive pregnancy test if of childbearing potential.
- •21. Lactating mothers.
- •22. Participation in any other clinical investigation that is likely to confound study results or affect the study.
- •23. Patients who have been placed in an institution by court order or by order of the authorities.
研究组 & 干预措施
Corheart 6 LVAS
Experimental
The Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) to be used on patients with advanced left ventricular heart failure.
干预措施: Corheart 6 Left Ventricular Assist System (Device)
结局指标
主要结局
Composite of surivival
时间窗: Up to 6 months post-implantation
At 6 months post-implantation, composite of survival to transplant, recovery, LVAS support free of disabling stroke (Modified Rankin Score \> 3), or re-operation to replace the pump due to pump failure.
次要结局
- Survival(Year 1, Year 2, Year 3, Year 4, Year 5)
- Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L)(Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5)
- Functional status as measured by the Six Minute Walk Test (6MWT)(Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5)
- Composite of surivival(Year 1, Year 2, Year 5)
- Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)(Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5)
- Functional status as measured by the New York Heart Association (NYHA) Classification(Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5)
- Adverse Events(As they occurred, from Baseline to Year 5)
研究者
研究点 (11)
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