NCT02170363已完成不适用
HeartMate 3™ CE Mark Clinical Investigation Plan
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 20
- 主要终点
- Survival
研究概览
简要总结
The purpose of this clinical investigation is to evaluate the performance and safety of the HeartMate 3 Left Ventricular Assist System (HM3 LVAS) To support obtaining CE Mark for the HM3 LVAS in Europe, a multi-center clinical study will be conducted in multiple countries. The clinical study will be conducted in compliance with the Declaration of Helsinki, ICH/GCP and EN ISO 14155:2011 Requirements for Clinical Investigations and in accordance with country-specific requirements, under one clinical study protocol.
This study will evaluate the performance of the HM3 LVAS, side effects and undesirable conditions within acceptable risks and weigh them against the intended performance of HM3 LVAS in accordance with Essential Requirements 2, 5 and 16 of the Active Implantable Medical Device Directive 90/385/EEC (AIMDD).
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
- •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
- •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,
- •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,
- •Inotrope dependent/unable to wean from inotropes
- •Listed for Transplant
- •Females of child bearing age must agree to use adequate contraception
排除标准
- •Etiology of 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 that will not be converted to a bioprosthesis at the time of LVAD implant
- •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 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
- •Patient has moderate to severe aortic insufficiency without plans for correction during pump implant
- •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
- •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 24 months
结局指标
主要结局
Survival
时间窗: 6 months
Comparison of survival at 6 months of Left Ventricular Assist Device (LVAD) support to a performance goal established using matched HeartMate II INTERMACS data
次要结局
- Functional Status - New York Heart Association (NYHA) Classification(Baseline, Month 1, Month 3, Month 6)
- Rehospitalizations(As they occurred, Baseline through 180 Days)
- Stroke Free Survival(6 months)
- All Adverse Events(As they occurred, Baseline through 180 Days)
- Quality of Life (EQ-5D-5L)(Baseline, Month 1, Month 3, Month 6)
- Device Malfunctions(As they occurred, Baseline through 180 Days; Subjects that remain ongoing after 6 months will continue to be followed to 24 months post-implant or outcome)
- Reoperations(As they occurred, Baseline through 180 Days)
- Functional Status - Six Minute Walk Test (6MWT)(Baseline, Month 1, Month 3, Month 6)
研究者
研究点 (20)
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