NL-OMON42831尚未招募不适用
St. Jude Medical HeartMate® PHP CE Mark Post Approval Study - PHP PAS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* At least 18 years of age.
- •* Patient presents with a non-emergent need for complex PCI and in the opinion of the investigator is a risk of hemodynamic compromise during PCI.
- •* 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
- •*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
研究者
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