NCT01493284已完成不适用
Assessment Of The St. Jude Medical Portico™ Transcatheter Aortic Valve Implant (TAVI) And The SJM TAVI Transfemoral Delivery System (Portico TF EU)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 15
- 主要终点
- All Cause Mortality
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and the SJM TAVI Transfemoral Transcatheter delivery system in subjects with severe symptomatic aortic stenosis (AS).
详细描述
Data will be collected at baseline, procedure, discharge, 30 days post implant, 3 months post implant, 6 months post implant, and 12 months post implant.
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
- •Subject has given written study Informed Consent for participation prior to procedure.
- •Subject is ≥ 18 years of age or legal age in host country.
- •Subject's aortic annulus diameter meets the range indicated in the Instructions for use as measured by echocardiogram (echo) or CT conducted within the past 90 days.
- •Subject has senile degenerative aortic stenosis with echocardiography (echo) derived mean gradient >40mmHg or jet velocity greater than 4.0 m/s or an initial valve area of <1.0 cm2 (or aortic valve area index ≤ 0.6 cm2/m2). (Baseline measurement taken by echo within 30 days of procedure).
- •Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II or greater.
- •Subject is deemed high operable risk and suitable for TAVI per the medical opinion of the Subject Selection Committee (See Section 3.1 for the definition of the Subject Selection Committee)
- •Subject's predicted operative mortality or serious, irreversible morbidity risk is <50% at 30 days.
- •In the opinion of the Subject Selection Committee and based upon angiographic measurements, the subject has suitable peripheral vessels and aorta to allow for access of the 18 French delivery system.
- •Subject has structurally normal cardiac anatomy.
- •Subject is willing and able to comply with all required follow-up evaluations.
排除标准
- •Subject has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months (≤180 days) of the index procedure.
- •Subject has carotid artery disease requiring intervention.
- •Subject has evidence of a myocardial infarction (MI) within the past 6 months (≤180 days) of the index procedure.
- •Subject has hypertrophic cardiomyopathy.
- •Subject has a native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
- •Subject has mitral or tricuspid valvular regurgitation (>grade III) or moderate to severe mitral stenosis.
- •Subject has aortic root angulation >70 degrees (horizontal aorta).
- •Subject has a pre-existing prosthetic valve or prosthetic ring in any position.
- •Subject refuses blood transfusion or surgical valve replacement.
- •Subject has left ventricular ejection fraction (LVEF) < 20%.
- •The subject has documented, untreated coronary artery disease (CAD) requiring revascularization.
- •Subject has severe basal septal hypertrophy.
- •Subject has had a percutaneous interventional or other invasive cardiac or peripheral procedure ≤ 14 days of the index procedure.
- •Subject has a history of or has active endocarditis.
- •Subject has echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
- •Subject has hemodynamic instability (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.
- •Subject has significant chronic steroid use.
- •Subject has a known hypersensitivity or contraindication to anticoagulant or antiplatelet medication.
- •Subject has renal insufficiency as evidenced by a serum creatinine > 3.0 mg/dL (265µmol/L) or end-stage renal disease requiring chronic dialysis.
- •Subject has morbid obesity defined as BMI ≥
- •Subject's iliac arteries have severe calcification, tortuosity (>two 90 degree bends), diameter <6mm, or subject has had an aorto-femoral bypass.
- •Subject has ongoing infection or sepsis.
- •Subject has blood dyscrasias (leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy).
- •Subject has a current autoimmune disease that, in the opinion of the Principal Investigator precludes the subject from study participation.
- •Subject has significant aortic disease, including:
- •aortic abdominal aneurysm (AAA) ≥ 4cm
- •thoracic aneurysm (defined as a maximal luminal diameter of 5 cm or greater)
- •marked tortuosity
- •significant aortic arch atheroma or narrowing of the abdominal or thoracic aorta
- •severe tortuosity of the thoracic aorta.
- •Subject has a pre-existing endovascular stent graft in the supra- or infrarenal aorta or pre-existing stent grafts in the ileo-femoral arteries.
- •Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 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 < 12 months.
- •Subject has other medical, social or psychological conditions that, in the opinion of the Subject Selection Committee, preclude the subject from study participation.
- •Subject is suffering from dementia or admitted to a chronic care facility which would fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits.
- •Subject has a known allergy to contrast media, nitinol alloys, porcine tissue, or bovine tissue.
研究组 & 干预措施
Transfemoral Access
Experimental
Transfemoral Access for transcatheter aortic valve implant
干预措施: Transcatheter Aortic Valve Implantation (Device)
结局指标
主要结局
All Cause Mortality
时间窗: 30 days
Number of participants that reported all cause mortality
次要结局
- Number of Select Cardiovascular Adverse Events(30 days)
- Participant NYHA Classification at Day 30(day 30)
- Number of Participants With Acute Device Success(7 days)
研究者
研究点 (15)
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