NCT02892955已完成不适用
Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ Continued Access Protocol: Post-Approval Continued Follow-up
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,685
- 试验地点
- 136
- 主要终点
- Event-Free Survival
研究概览
简要总结
The objective of the study is to continue to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the the MOMENTUM 3 IDE Study.
详细描述
Enrollment in the CAP cohort ended shortly after approval for the long-term indication was received from the FDA in October 2018. As a condition of approval, all patients enrolled in the CAP cohort were to complete the 2-year follow-up to fulfil a post-approval study requirement.
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 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 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 cardiac 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 Abdominal Aortic Aneurysm (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 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 ≥ 2.0 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 artery 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
- •Patients actively listed for heart transplant (this exclusion applies only after commercial approval of the HM3 for short-term use)
结局指标
主要结局
Event-Free Survival
时间窗: Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.
Survival at 24 months free of disabling stroke (Modified Rankin Score \> 3) or reoperation to replace or remove a malfunctioning device
次要结局
- Pump Replacement(As they occur up to 24 months or to outcome, whichever occurs first)
- New York Heart Association (NYHA) Classification(Baseline, 6 months and 24 months)
- EuroQol-5D-5L Visual Analogue Scale(Baseline, 6 months and 24 months)
- Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score(Baseline, 6 months and 24 months)
- Adverse Event Rates(2 years post-implant)
- Rehospitalizations(From initial discharge to 2 years post-implant)
- Six Minute Walk Test (6MWT)(Baseline, 6 months and 24 months)
研究者
研究点 (136)
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