Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVI: a Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 18
- 主要终点
- Total TAVI procedural duration
研究概览
简要总结
The purpose of this study is to determine whether a left ventricular rapid pacing using the valve delivery guide-wire in transcatheter aortic valve implantation (TAVI) reduces the overall procedure duration in comparison with the conventional method.
详细描述
Use of temporary pacing via a right ventricular lead in TAVI is still mandatory to ensure transient cardiac standstill while predilatation is performed and the valve is being positioned and deployed. This requires an additional venous vascular access and a pacing catheter which are both likely to generate complications.
This study compares the standard right ventricular rapid pacing to a new and simplified technique : a left ventricular rapid pacing is provided via the back-up 0.035 " guidewire. The cathode of an external pacemaker is placed on the tip of the 0.035" wire and the anode on a needle inserted into the groin. Insulation is ensured by the balloon or TAVI catheter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is eligible for a TAVI
- •Access considered for aortic valve bioprothesis delivery is transfemoral
- •Aortic valve bioprothesis considered is Edwards Sapien 3® et/ou XT®
- •Subject is ≥ 18 years of age
- •Subject has signed informed consent form
排除标准
- •Pregnancy
- •Subject already included in this study
- •Subject included in another study and whose inclusion in EASY TAVI implies a deviation in either study
结局指标
主要结局
Total TAVI procedural duration
时间窗: 1 month
Duration of TAVI procedure is calculated from the first puncture to the last sheath removal
次要结局
- Incidence of the experimental technique on succes rate of the intervention, fluoroscopy time, radiation exposure, Major adverse cardiovascular event and tamponades (Safety)(1 month)
- Incidence of the experimental technique on direct and indirect costs (Cost-effectiveness)(1 month)
- Efficacy of the experimental technique to create a blood pressure drop reaching at least 60 mmHg (Ventricular stimulation efficiency)(1 month)