First In Human Experience and Assessment of the 23mm SJM Transcatheter Aortic Valve Implant and the SJM TAVI Transfemoral Delivery System (SJM TAVI FIH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Assessment of Technical Feasibility and Device Deployment Characteristics
研究概览
简要总结
The purpose of this first-in-human study is to assess the technical feasibility, deployment characteristics, and safety of the 23mm SJM Transfemoral Transcatheter Heart Valve and delivery system in subjects with severe symptomatic aortic stenosis (AS).
This is a single center, prospective, non-randomized, first-in-human investigational study without concurrent or matched controls.
详细描述
Data will be collected at baseline, procedure, discharge (date of hospital discharge or 7 days post-implant, whichever occurs first), 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
- •Written Informed Consent for participation prior to procedure.
- •Legal age in host country.
- •Aortic annulus 19-21mm diameter
- •Senile degenerative aortic stenosis with 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)
- •NYHA Functional Classification of II or greater.
- •Predicted operative mortality or serious, irreversible morbidity risk is <50% at 30 days.
- •Suitable peripheral vessels and aorta to allow for access of the 18 French delivery system.
排除标准
- •History of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months (≤180 days) of index procedure.
- •Carotid artery disease requiring intervention.
- •Myocardial infarction (MI) within 6 months (≤180 days) of the index procedure.
- •Native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
- •Mitral or tricuspid valvular regurgitation (grade II) or moderate to severe mitral stenosis.
- •Aortic root angulation >70 degrees (horizontal aorta).
- •Pre-existing prosthetic valve or prosthetic ring in any position. LVEF < 20%.
- •Untreated coronary artery disease (CAD) requiring revascularization.
- •Severe basal septal hypertrophy.
- •Percutaneous interventional or other invasive cardiac or peripheral procedure ≤ 14 days or history of previous endocarditis.
- •Uncontrolled atrial fibrillation (AF) or is in chronic AF without long term oral anticoagulation.
- •Evidence of intracardiac mass, thrombus, or vegetation.
- •Hemodynamic instability
- •Significant pulmonary disease.
- •Nonreactive pulmonary hypertension.
- •Chronic steroid use.
- •Hypersensitivity or contraindication to anticoagulant or antiplatelet medication.
- •Renal insufficiency as evidenced by a serum creatinine > 3.0 or end-stage renal disease requiring chronic dialysis.
- •Morbid obesity defined as BMI ≥
- •Subject's iliac arteries have severe calcification, tortuosity, diameter <6mm, or subject has had an aorto-femoral bypass.
- •Ongoing infection or sepsis.
- •Blood dyscrasias
- •Significant aortic disease.
- •Pre-existing endovascular stent graft in the supra- or infrarenal aorta or pre-existing stent grafts in the ileo-femoral arteries.
- •Active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 3 months (≤ 90 days) prior to the index procedure.
结局指标
主要结局
Assessment of Technical Feasibility and Device Deployment Characteristics
时间窗: At time of procedure
Evaluate the technical feasibility and device deployment characteristics (observed at procedure) by: 1. The ability for the valve to be deployed at the desired location 2. The ability to complete the full procedure 3. Quantification of the time from delivery system entry to a fully deployed and functional valve
次要结局
- Quantification of SAEs Reported (Device Related or Procedure Related)(Through 12 months post implantation)