Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 55
- 试验地点
- 7
- 主要终点
- Capability to monitor LBB success criteria with the use of Smart ECG system
研究概览
简要总结
To evaluate the capability to monitor LBB success criteria with the use of a Smart ECG system (ECG monitor, 12 leads ECG cable, ECG viewer software ) during a cardiac device implantation involving the placement of a pacing lead in interventricular septum area
详细描述
The clinical investigation aims to support physicians with a portable and easy to use solution to display ECG and to provide automatic calculation of key ECG indicators (Left Ventricular Activation time (LVAT) and V6-V1 interval) for LBB implantation procedure. This allows physicians to concentrate on lead placement with the benefice from immediate ECG measurements thanks to the automatic software.
The Smart ECG system is class IIA device and it is composed of:
- CE-marked Smart ECG, Class IIa medical device (rule 10 Annex VIII of MDR)
- ECG viewer Software (HookUp SmarV2) (providing 12 lead ECG display + automatic interval measurements + shadow plot for QRS visualization) Class IIa medical device (rule 11 Annex VIII of MDR).
- CE -marked 12 leads ECG cables radiotransparent and defibrillation proof (Class I device)
- Commercial PC used in combination with the devices under evaluation
The study is a pre-market, non-pivotal study: HookUp Smart V2 software is a non-implantable Class IIA device, with no interaction with the human body and the demonstration of conformity with general safety and performance requirements is based on the results of non-clinical testing methods alone (as article 61(10) from MDR.
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
- 是
入选标准
- •Subject with indication for LBBAP using an Electrophysiology ECG monitoring system (EP System) as part of pacemaker or CRT-P or CRT-D implant procedure (de novo implant, device revision or upgrade including LOT-CRT)
- •Subject signed and dated the ICF
排除标准
- •Incapacitated subject or under guardianship
- •inability to understand the purpose of the study
- •Minor subjects
- •Non menopausal women
- •Patients implanted with other electrically active non cardiac devices.
结局指标
主要结局
Capability to monitor LBB success criteria with the use of Smart ECG system
时间窗: baseline/ procedure
Proportion of investigators providing an overall favorable assessment (assessed "GOOD or ACCEPTABLE") on a four- point scale (GOOD, ACCEPTABLE, POOR, VERY POOR) on the use of Smart ECG system to achieve LBB area pacing.
次要结局
- Identification of LBB transitions(baseline/ procedure)
- The accuracy of the two measurements (LVAT and V6-V1)(baseline/ procedure)
- Type of LBB capture(baseline/ procedure)
- Signal quality analysis(baseline/ procedure)
- Investigator's satisfaction(baseline/ procedure)
- Safety reporting(baseline/ procedure)