Collection of SPOT EGMs And inTra-Cardiac Impedance for Atrio-ventricUlar and inteR-ventricular Delays optimizatioN
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 35
- 试验地点
- 6
- 主要终点
- Signals timing vs LPEI
研究概览
简要总结
The purpose of the study is to collect data from the two implanted sensors simultaneously to the surface ECG and echocardiographic measurements of electromechanical parameters, in CRT patients.
详细描述
The SATURN study is a prospective, interventional, open-label, non-randomized, single-arm, acute, multicenter feasibility study.
The purpose of the study is to collect data from the two implanted sensors simultaneously to the surface ECG and echocardiographic measurements of electromechanical parameters.
The data collected will be analysed in order to explore the relevance of timings and morphological features derived from those signals in comparison with timings determined on echocardiography and electrocardiograms (ECG) in various configurations of atrioventricular (AV) and inter-ventricular (VV) delays.
A maximum of 35 subjects, implanted with a CRT-D device, will be enrolled, at approximately 6 sites in France. Each patient will participate to this study only during an echocardiographic procedure, whose duration is estimated in approximately 1.5 hour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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 class I or II indication for implantation of a CRT-D device according to current ESC guidelines
- •Patient newly implanted with a MicroPort CRM Platinium CRT-D SonR or Platinium CRT-D device within 2 months before the Investigational Procedure
- •Patient in sinus rhythm with a preserved atrio-ventricular conduction, and PR interval=220 +/- 30 ms on surface ECG
- •Patient has reviewed, signed and dated the study informed consent form
排除标准
- •Patient with permanent or persistent atrial fibrillation or atrial flutter
- •Patient presenting with a permanent or frequent paroxysmal high degree atrio-ventricular block
- •Device upgrade or replacement
- •Minor patient (i.e. under 18 years of age), or patient under guardianship or kept in detention
- •Patient unavailable for the scheduled Investigational Procedure, not able to understand the purpose of this study or refusing to cooperate
结局指标
主要结局
Signals timing vs LPEI
时间窗: Participants will be tested during a single clinic visit, at the enrolment in the study (Day 0)
An exploratory analysis on the relation between timings derived from the signals acquired with CRT implanted devices, and LPEI (Left Pre-Ejection Interval) determined by echography in multiple configurations of atrio-ventricular (AV) and inter-ventricular (VV) delays.
次要结局
未报告次要终点