Interest of Cardiac Computed Tomography (CT) to Optimize and Improve the Procedure of Transcatheter Aortic Valve Implantation (TAVI)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Composite end point
研究概览
简要总结
This is a pilot prospective, comparative, monocentric, randomized study with 2 groups. People with a severe aortic stenosis and a high risk of surgery are referred to a Trans catheter aortic valve implantation (TAVI).
详细描述
The proposed study is to show the interest of a cardiac computed tomography (CT) to improve the TAVI procedure. The Cardiac computed tomography (CT) shows the exact geometry of the aortic annulus and help the physician to find the right position of the prosthesis during the procedure. The hypothesis is that performing a cardiac CT before the TAVI could reduce the number of vascular peripheral complication, the number of stroke and can minimize the aortic regurgitation during the follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patient with a symptomatic severe aortic stenosis with a too high risk of surgical valvular replacement. This patient will be selected for a TAVI. In this study, we only randomized patient for a TAVI with an Edwards prosthesis
- •male or female patient, older than eighteen years old
- •who have given their written consent
- •who are affiliated to the French social security system
- •which has a too high risk of surgical valvular replacement (EuroSCORE logistic > 20% or Society of Thoracic Surgeons Score > 10, or contre indicated to a cardiac surgery by a heart team
- •Severe Aortic stenosis with symptoms like dyspnea, heartache, syncope, heart failure
排除标准
- •Patient who can't give his written consent because of his physical or mental status
- •Adult patient protect by law (article L1121-8),
- •Person deprived of liberty (article L1121-8),
- •Pregnant women
- •Patient in terminal phase of illness,
- •Terminal kidney failure
- •Allergy to iodine
- •bicuspids ou unicuspid aortic,
- •Diameter of the left ventricular outflow tract < 18mm or > 25mm,
- •Diameter of the femoral artery < 7mm, tortuosity or calcifications
- •Septal hypertrophy
- •Apical thrombosis.
结局指标
主要结局
Composite end point
时间窗: participants will be followed for the duration of 1 year
Composite end point with Stroke (symptoms and CT or MRI), Vascular complications (hematoma with the need of transfusion, dissection of artery/ legs ischemia), and Aortic regurgitation after the procedure, evaluated by transthoracic echocardiography
次要结局
- To compare results of transthoracic / transoesophageal echocardiography and cardiac CT(inclusion visit)