First in Human Experience of the St. Jude Medical TAVI Valve and Delivery System (SJM TAVI FIH)
First In Human Experience and Assessment of the 23mm SJM Transcatheter Aortic Valve Implant and the SJM TAVI Transfemoral Delivery System (SJM TAVI FIH)
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.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Belfast、英国
- Royal Victoria Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 ≥ 35.
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Subjects receiving TAVI valve
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Placement of the SJM TAVI aortic valve with a transfemoral delivery system.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Assessment of Technical Feasibility and Device Deployment Characteristics
大体时间:At time of procedure
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Evaluate the technical feasibility and device deployment characteristics (observed at procedure) by:
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At time of procedure
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Quantification of SAEs Reported (Device Related or Procedure Related)
大体时间:Through 12 months post implantation
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Evaluate the safety of the 23mm SJM Transcatheter Aortic Heart Valve and transfemoral delivery system by:
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Through 12 months post implantation
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合作者和调查者
调查人员
- 首席研究员:Ganesh Manoharan, MD、Royal Victoria Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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