Cardiac Resynchronization Under Electroanatomical Guidance After Failure of Primary Implantation: CRT3D Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Setting up with success of the Left Ventricular lead
研究概览
简要总结
The purpose of the study is to assess the feasibility of cardiac resynchronization under electroanatomic guidance in the event of primary implantation failure due to catheterization failure or instability in the coronary sinus ostium
详细描述
As part of this study, to avoid surgery, the doctor will use a 3-dimensional (3D) guidance technique to position the heart probes in an optimal position during a new endovascular intervention.
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
- •Patient with indication for implantation of a classic multisite pacemaker;
- •New York Heart Association II/IV patient despite optimal medical treatment;
- •Patient with left ventricular ejection fraction ≤35%;
- •Patient with a widened QRS > 120ms;
- •Patient with at least one lateral coronary sinus vein visualized on angiography during the 1st procedure (if performed);
- •Patient with failure of resynchronization via the endovenous route due to difficulty in accessing the coronary sinus or instability in the coronary sinus;
- •Patient having been informed and having signed an informed consent form;
- •Patient able to understand the information related to the study (absence of linguistic, psychological, cognitive problem, etc.), and to complete questionnaires.
排除标准
- •Patient with resynchronization failure due to occlusion of the superior vena cava;
- •Patient with no usable lateral coronary sinus vein;
- •Patient with a life expectancy < 3 months;
- •Patient wearing a vena cava filter;
- •Patient with active sepsis;
- •Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding;
- •Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
- •Patient not benefiting from a social security scheme.
结局指标
主要结局
Setting up with success of the Left Ventricular lead
时间窗: during the time of the setting up of the pace maker
Feasibility of cardiac resynchronization under 3 dimension assistance in the event of primary implantation failure will be assessed by the proportion of patients for whom the Left Ventricular lead has been placed successfully with a pacemaker
次要结局
未报告次要终点