NCT02475460已完成不适用
Thoratec Corporation HeartMate 3™ Less Invasive Surgery (LIS) Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 6
- 主要终点
- Number of survival participants
研究概览
简要总结
The purpose of this study is to evaluate a less invasive implantation technique of the HeartMate 3 Left Ventricular Assist System (HM 3 LVAS) in 10 patients.
详细描述
This study will evaluate the less invasive implantation technique of the HM 3 LVAS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Patient or legal representative has signed Informed Consent Form (ICF)
- •Age ≥ 18 years
- •BSA ≥ 1.2 m2
- •NYHA IIIB or IV, or ACC/AHA Stage D
- •CI ≤ 2.2 L/min/m2, while not on inotropes (if Patient is treated with inotropes at baseline, this does not apply)
- •Patients must also meet one of the following:
- •On optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and are failing to respond, OR
- •In NYHA class IIIB or IV heart failure for at least 14 days AND dependent on intraaortic balloon pump (IABP) for at least 7 days, OR
- •Inotrope dependent/unable to wean from inotropes OR
- •Listed for transplant
- •Females of child bearing age must agree to use adequate contraception-
排除标准
- •Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy
- •Technical obstacles which pose an inordinately high surgical risk, in the judgment of the Investigator
- •Existence of ongoing mechanical circulatory support (MCS) other than IABP
- •Positive pregnancy test if of childbearing potential
- •Lactating mothers
- •Presence of mechanical aortic cardiac valve
- •History of any organ transplant
- •Platelet count < 100,000 x 103/L (< 100,000/ml)
- •Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management
- •History of confirmed, untreated AAA > 5 cm in diameter
- •Presence of an active, uncontrolled infection
- •Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy that the Investigator will require based upon the patients' health status
- •Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
- •An INR ≥ 2.5 not due to anticoagulation therapy
- •Total bilirubin > 43 umol/L (2.5 mg/dl), shock liver, or biopsy proven liver cirrhosis
- •History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, or FEV1 <50% predicted
- •Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention
- •History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 80%) carotid artery stenosis
- •Serum Creatinine ≥ 221umol/L (2.5 mg/dl) or the need for chronic renal replacement therapy
- •Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration
- •Aortic valve regurgitation > grade 1
- •Pre albumin < 150 mg/L, or Albumin < 30g/L (3 g/dL)
- •Planned Bi-VAD support prior to enrollment
- •Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia
- •Planned concomitant intra-cardiac cardiac surgery
- •Thrombus formation in the atrium or left ventricle identified by echocardiogram
- •Previous sternotomy or left-sided thoracotomy
- •Participation in any other clinical investigation that is likely to confound study results or affect the study
- •Any condition other than HF that could limit survival to less than 6 months
结局指标
主要结局
Number of survival participants
时间窗: 30 days
次要结局
未报告次要终点
研究者
研究点 (6)
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