HeartMate PHP™ CE Mark Clinical Investigation Plan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 12
- 主要终点
- Primary Endpoint
研究概览
简要总结
The HeartMate PHP is a catheter-based pump designed to provide partial left heart circulatory support. The study will assess the safety and performance of the HeartMate PHP in supporting patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing percutaneous coronary interventions (PCI), such as coronary stent placement.
详细描述
The HeartMate PHP (percutaneous heart pump) is a catheter-based axial flow pump designed to provide partial left ventricular circulatory support. The primary objective of this prospective, nonrandomized, multi-center, open-label trial is to assess the safety and performance of the HeartMate PHP in supporting patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing percutaneous coronary interventions (PCI).
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
- •At least 18 years of age.
- •Patient presents with a non-emergent need for complex PCI with:
- •an ejection fraction of ≤35% requiring hemodynamic support during the procedure, AND
- •the heart team has determined that the patient is not an optimal surgical candidate, OR the patient elects not to undergo surgery
- •Written, signed, and dated informed consent
排除标准
- •Emergent PCI
- •ST elevation myocardial infarction within 7 days of procedure
- •Cardiac arrest within 7 days of procedure requiring CPR or defibrillation
- •Hemodynamic support with the HeartMate PHP post-PCI is anticipated
- •Cardiogenic shock (SBP <90 mmHg for >1 hour with either cool clammy skin OR oliguria OR altered sensorium OR cardiac index <2.2 L/min/m2)
- •Mural thrombus in the left ventricle
- •History of aortic valve replacement
- •Documented presence of aortic stenosis (orifice area of 1.5cm2 or less)
- •Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as 2 or higher)
- •Severe peripheral vascular disease
- •Abnormalities of the aorta that would preclude surgery, including aneurysms and significant tortuosity or calcifications
- •Planned use of rotablator or atherectomy during the procedure
- •Serum creatinine > 3.5mg/dL within 7 days of procedure
- •Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3x ULN or INR (Internationalized Normalized Ratio) ≥2
- •Uncorrectable abnormal coagulation parameters
- •Active systemic infection requiring treatment with antibiotics
- •Clinically relevant stroke or TIA within 3 months of procedure. Patients with suspected stroke or TIA within 3 months of procedure must have documented absence of neurological infarction
- •Uncontrollable allergy or intolerance to heparin, aspirin, clopidogrel, ionic and nonionic contrast media, or any other potentially required anticoagulants or antiplatelet therapy drugs
- •History of heparin induced thrombocytopenia
- •Patient is pregnant or planning to become pregnant during the study period
- •Participation in another clinical study of an investigational drug or device that has not met its primary endpoint-
结局指标
主要结局
Primary Endpoint
时间窗: Post procedure or at hospital discharge (whichever is longer), 30 days post procedure
Primary Performance Endpoint: Freedom from hemodynamic compromise during PCI procedure defined as: Mean Arterial Pressure (MAP) not falling below 60mm Hg for more than 10 minutes during the PCI procedure and additional pressor medication is not required. Primary Endpoint will be evaluated at: * Post procedure or at hospital discharge (whichever is longer) * 30 days post procedure
Composite of Major Adverse Events (MAE)
时间窗: Post procedure or at hospital discharge (whichever is longer), 30 days post procedure
Primary Safety Endpoint: Composite of Major Adverse Events (MAE): * device-related cardiac death, * new Q wave myocardial infarction, * surgical intervention due to device complication or malfunction, * device-related access site complication requiring intervention or device-related limb ischemia, * cerebral vascular accident (CVA), * new or worsening aortic valve insufficiency, * major bleeding complication (BARC 3 or \>), * severe hypotension Primary Endpoint will be evaluated at: * Post procedure or at hospital discharge (whichever is longer) * 30 days post procedure
次要结局
- Secondary Endpoint(Post procedure or at hospital discharge (whichever is longer), 30 days post procedure)
- Major Adverse Event Composites(Post procedure or at hospital discharge (whichever is longer), 30 days post procedure)