NCT02088021撤回不适用
Assessment of the St. Jude Medical PorticoTM Re-sheathable Aortic Valve System - Alternative Access
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- All cause mortality
研究概览
简要总结
The purpose of this clinical investigation is to evaluate the use of the Portico ALC Delivery System to place a transcatheter aortic valve through an alternative access site, specifically subclavian/axillary or TAo.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has provided written informed consent.
- •Subject is 65 years of age or older at the time of index procedure, and/or has comorbidities that, in the opinion of the Principal Investigator or the Subject Selection Committee, preclude surgical valve replacement.
- •Subject's aortic annulus diameter meets the range indicated in the Instructions for Use as measured by multislice CT conducted within 120 days prior to the index procedure.
- •Subject has senile degenerative aortic stenosis with echocardiography within 30 days of index procedure as defined by at least 1 of the following:
- •derived mean gradient greater than 40 mmHg, OR
- •jet velocity greater than 4.0 m/s, OR
- •aortic valve area of less than 0.8 cm2, OR
- •aortic valve area index less than or equal to 0.6 cm2/m
- •Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II, III, or IV.
- •Subject is deemed high operable risk and delivery route is suitable for TAVI per the medical opinion of the Subject Selection Committee.
- •Subject's predicted operative mortality or serious, irreversible morbidity risk is less than 50% at 30 days post index procedure.
排除标准
- •Subject is unwilling or unable to comply with all study-required follow-up evaluations.
- •Subject has a documented history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within 6 months (less than or equal to 180 days) prior to the index procedure.
- •Subject has carotid artery disease requiring intervention.
- •Evidence of an acute myocardial infarction (MI) within 30 days prior to patient providing consent (defined as: ST Segment Elevation as evidenced on 12 Lead ECG).
- •Subject has a native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
- •Subject has mitral valvular regurgitation greater than grade III.
- •Subject has moderate or severe mitral stenosis.
- •Subject has a pre-existing prosthetic cardiac device, valve, or prosthetic ring in any position.
- •Subject refuses any blood product transfusion.
- •Subject refuses surgical valve replacement.
- •Subject has left ventricular ejection fraction (LVEF) less than 20%.
- •Subject has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization.
- •Subject has had a percutaneous interventional or other invasive cardiovascular or peripheral vascular procedure less than or equal to 14 days of index procedure.
- •Subject has severe basal septal hypertrophy that would interfere with transcatheter aortic valve placement.
- •Subject has a history of, or is currently diagnosed with endocarditis.
- •There is imaging evidence of intracardiac mass, thrombus, or vegetation.
- •Subject is considered hemodynamically unstable (requiring inotropic support or mechanical heart assistance).
- •Subject is in acute pulmonary edema or requiring intravenous diuretic therapy to stabilize heart failure.
- •Subject with significant pulmonary disease as determined and documented by the Investigator.
- •Subject has significant chronic steroid use as determined and documented by the Investigator.
- •Subject has a documented hypersensitivity or contraindication to anticoagulant or antiplatelet medication.
- •Subject has renal insufficiency as evidenced by a serum creatinine greater than 3.0 mg/dL (265.5 µmol/L) or end-stage renal disease requiring chronic dialysis.
- •Subject has morbid obesity defined as a BMI greater than or equal to
- •Subject has ongoing infection or sepsis.
- •Subject has blood dyscrasias (eg, leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy).
- •Subject has a current autoimmune disease that, in the opinion of the Principal Investigator or the Subject Selection Committee, precludes the subject from study participation.
- •Significant ascending aortic disease documented by diameter greater than 40mm.
- •Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within 90 days prior to the index procedure.
- •Subject is currently participating in another investigational drug or device study.
- •Subject requires emergency surgery for any reason.
- •Subject has a life expectancy less than 12 months.
- •Subject has other medical, social or psychological conditions that, in the opinion of the Principal Investigator or the Subject Selection Committee, preclude the subject from study participation.
- •Subject is diagnosed with dementia or admitted to a chronic care facility which would fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits.
- •Subject is unwilling or unable to comply with all study-required follow-up evaluations.
- •Subject has a documented history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within 6 months (less than or equal to 180 days) prior to the index procedure.
- •Subject has carotid artery disease requiring intervention.
- •Evidence of an acute myocardial infarction (MI) within 30 days prior to patient providing consent (defined as: ST Segment Elevation as evidenced on 12 Lead ECG).
- •Subject has a native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
- •Subject has mitral valvular regurgitation greater than grade III.
- •Subject has moderate or severe mitral stenosis.
- •Subject has a pre-existing prosthetic cardiac device, valve, or prosthetic ring in any position.
- •Subject refuses any blood product transfusion.
- •Subject refuses surgical valve replacement.
- •Subject has left ventricular ejection fraction (LVEF) less than 20%.
- •Subject has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization.
- •Cardiovascular or peripheral vascular procedure less than or equal to 14 days of index procedure.
- •Subject has severe basal septal hypertrophy that would interfere with transcatheter aortic valve placement.
- •Subject has a history of, or is currently diagnosed with endocarditis.
- •There is imaging evidence of intracardiac mass, thrombus, or vegetation.
- •Subject is considered hemodynamically unstable (requiring inotropic support or mechanical heart assistance).
- 另有 16 项未显示
研究组 & 干预措施
Portico Transcatheter Aortic Valve Implantation
Experimental
Placement of the SJM Portico aortic valve with a ALC delivery system
干预措施: Portico Transcatheter Aortic Valve (Device)
结局指标
主要结局
All cause mortality
时间窗: 30 day post procedure
Major Vascular Complications related to the Portico ALC Delivery System
时间窗: 30 day post procedure
次要结局
- Event Rates(30 days post procedure)
- Functional improvement from baseline(30 days post procedure)
- Acute device success(12 months post procedure)
研究者
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