NCT02224755已完成不适用
Thoratec Corporation MOMENTUM 3, Multi-center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ IDE Clinical Study Protocol
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,028
- 试验地点
- 136
- 主要终点
- Short Term Primary End Point
研究概览
简要总结
The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.
详细描述
The HM3 LVAS is intended to provide hemodynamic support in patients with advanced, refractory left ventricular heart failure; either for short term support, such as a bridge to cardiac transplantation (BTT) or myocardial recovery, or as long term support, such as destination therapy (DT). The HM3 is intended for use inside or outside the hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject or legal representative has signed Informed Consent Form (ICF)
- •Age ≥ 18 years
- •BSA ≥ 1.2 m2
- •NYHA Class III with dyspnea upon mild physical activity, or NYHA Class IV
- •a) Inotrope dependent OR b) CI < 2.2 L/min/m2, while not on inotropes and subjects 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
- •Advanced Heart Failure for at least 14 days AND dependent on intra-aortic balloon pump (IABP) for at least 7 days
- •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
- •Presence of mechanical aortic valve that will not be either converted to a bioprosthesis or oversewn 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 within 6 months of enrollment
- •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 ≥ 2.0 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, and 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%) uncorrected carotid stenosis
- •Serum creatinine ≥ 221 umol/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 (15mg/dL) or Albumin < 30g/L (3 g/dL) (if only one available) ; pre albumin < 150 mg/L (15mg/dL) and Albumin < 30g/L (3 g/dL) (if both available)
- •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
Short Term Primary End Point
时间窗: The first 294 randomized Subjects will be followed for 6 months or to outcome (transplant, explant, or death), whichever occurs first.
Survival at 6 months free of disabling stroke (Modified Rankin Score \> 3) or reoperation to replace or remove a malfunctioning device
Long Term Primary End Point
时间窗: The first 366 randomized Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.
Survival at 2 years free of disabling stroke (Modified Rankin Score \> 3) or reoperation to replace or remove a malfunctioning device
次要结局
- Adverse Event Rates(Two years post-implant)
- Powered Secondary End Point: Pump Replacement at Two Years(As they occur up to 24 months or to Outcome, whichever occurs first)
- EuroQoL 5D-5L (EQ-5D-5L) Total Score(Baseline to 24 months)
- EuroQol-5D-5L Visual Analogue Scale(Baseline to 24 months)
- Six Minute Walk Test(Baseline to 24 months)
- New York Heart Association (NYHA) Classification(Baseline to 24 months)
- Rehospitalizations(From initial discharge to two years post-implant)
- Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score(Baseline to 24 months)
研究者
研究点 (136)
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