NCT05695716撤回不适用
Cardiovascular Systems, Inc. (CSI) Percutaneous Ventricular Assist Device (pVAD) Second in Human Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- CSI pVAD System device placement/procedural success
研究概览
简要总结
The purpose of this study is to collect data on safety and device performance on the CSI pVAD System used to support hemodynamic stability during HR-PCIs to inform device design and finalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- 是
入选标准
- •Subject is ≥18 years of age
- •In the investigator's opinion, the subject is capable of providing informed consent.
- •Subject has signed the Independent Ethics Committee (IEC) approved study Informed Consent Form (ICF) prior to any study related procedures
- •Subject has a life expectancy ≥1 year
- •Subject has a left ventricular ejection fraction (LVEF) ≥15% and ≤40%
- •Subject has a planned elective or urgent high risk percutaneous coronary intervention with hemodynamic support
- •Subject of child bearing potential has a negative pregnancy test result
排除标准
- •Subject has ST-Elevation Myocardial Infarction (STEMI) within 30 days prior to study procedure based on criteria in SCAI definition
- •Subject has NSTEMI with cardiac enzymes that are not trending downward within 30 days prior to study procedure
- •Subject with RV failure (defined as reduced RV function on imaging and evidence of increased CVP >18 mmHg)
- •Subject with history of cardiac arrest within 30 days prior to study procedure requiring cardiopulmonary resuscitation OR any history of cardiac arrest with impairment in mental status, cognition or any global or functional neurological deficit
- •Subject is in cardiogenic shock (defined as systolic BP <90 mmHg, cardiac index <2.1 and/or evidence of impaired end organ perfusion) that is not responsive to fluid infusion or requiring any inotropic or pressor support
- •Subject received any pressors or inotropes within 24 hours prior to the start of the study procedure
- •Subject has evidence of current or prior endocarditis
- •Subject with active myocarditis
- •Subject had a deep vein thrombosis (DVT) or pulmonary embolism (PE) within 6 months prior to study procedure
- •Subject had a stroke or TIA within 6 months prior to study procedure
- •Subject had previous CABG within 6 months prior to study procedure
- •Subject had coronary intervention within 30 days prior to study procedure
- •Subject has a coronary intervention planned within 30 days post procedure
- •Subject has presence of left ventricular (LV) mural thrombus
- •Subject has history of valve replacement or repair (e.g., MitraClipTM) including transcatheter edge to edge repair (TEER)
- •Subject has significant mitral valve disease (defined as mitral regurgitation greater than moderate, grade ≥2+ by echocardiogram (ECHO), mitral stenosis with MVA <1.5 cm2) or has evidence of structural damage to the chordae tendineae or valve
- •Subject has significant aortic valve disease (defined as aortic stenosis (valve area ≤1.5 cm2 or moderate or severe aortic regurgitation (grade ≥2+ by ECHO))
- •Subject with atrial fibrillation present at the time of enrollment or any time prior to RHC or CSI pVAD device placement
- •Subject has sustained tachycardia with heart rate over 120 BPM
- •Subject has sustained ventricular tachycardia either pre- or during intervention
- •Subject has severe pulmonary hypertension, defined as mean pulmonary artery pressure ≥40 mmHg
- •Subject has presence of an aneurysm or dissection along vascular delivery path including:
- •Abdominal aortic aneurysm 4.0 cm or greater, OR
- •Significant descending thoracic aortic aneurysm greater than 4.5 cm, OR
- •Any dissection of the ascending, transverse, or descending aorta
- •Subject has severe peripheral vascular disease that will preclude the use of a 12Fr access sheath, which is required for the insertion of the CSI pVAD catheter
- •Subject has severe aortic tortuosity
- •Subject has severe aortic calcification that may preclude appropriate placement of the CSI pVAD device
- •Subject's vasculature will not tolerate a right heart catheterization (RHC)
- •Subject has chronic renal dysfunction defined by either:
- •Serum creatinine ≥ 2.5 mg/dl AND/OR
- •Requires hemodialysis
- •Subject has liver dysfunction with either:
- •Elevation of liver enzymes and bilirubin levels to ≥ 3X ULN OR
- •Internationalized Normalized Ratio (INR) ≥ 2 OR
- •Lactate dehydrogenase (LDH) > 2.5X ULN
- •Subject has uncorrectable abnormal coagulation parameters defined as either:
- •Platelet count ≤75,000 per μL OR
- •INR ≥2.0 or
- •Subject has history of heparin induced thrombocytopenia
- •Subject has history of bleeding diathesis or known coagulopathy, any recent GU or GI bleed within 30 days prior to study procedure or will refuse blood transfusions
- •Subject has anemia (hemoglobin <10.0 g/dL) or polycythemia/hypovolemia (hemoglobin >16.5 g/dL)
- •Subject requires, or, in the clinical judgement of the investigators may need, long term support (>6 hours) with a commercially available mechanical circulatory support (MCS) device
- •Subject was on any mechanical cardiac support device at any time within 14 days prior to the study procedure.
- •Subject has an active systemic infection requiring oral or intravenous antibiotics, or elevated temperature or white blood cell count that may be due to infection
- •Subject has been diagnosed with COVID ≤10 days prior to study procedure or is excluded due to COVID based on institution or other (e.g., CDC) guidelines
- •Subject has an allergy or intolerance to ionic and nonionic contrast media, anticoagulants, or antiplatelet therapy drugs that cannot be adequately premedicated
- •Subject has an allergy or intolerance to CSI pVAD System components
- •Subject is pregnant
- •Subject is currently participating or plans to participate in another investigational drug- or device trial that may affect any of this study's endpoints
- 另有 2 项未显示
结局指标
主要结局
CSI pVAD System device placement/procedural success
时间窗: Intraprocedural
Delivery of the device to the correct anatomical position, successful operation and removal of the CSI pVAD system
Prevention of severe hypotension while on CSI pVAD device support
时间窗: Intraprocedural
Percentage of subjects who were free from severe hypotension while on CSI pVAD device support.
Major Device-Related Adverse Events
时间窗: from Intraprocedure through study exit at 30 day follow up
Percentage of subjects who were free from: * Access site complications, defined as complications requiring unplanned transfusion of packed red blood cells (1 unit or more) and/or percutaneous or surgical intervention * Bleeding (BARC category 3 or 5, and category 2 if serious criterion is met) * Cardiovascular death * Clinically significant myocardial infarction (MI), classified based on the SCAI and Fourth Universal definitions * Stroke (ischemic or hemorrhagic), classified based on symptoms on CT or MRI imaging
次要结局
未报告次要终点
研究者
研究点 (1)
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