Conduction System Pacing Display Research System for SmartSync Pacing System Analyzer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Left Ventricular Activation Time (LVAT)
研究概览
简要总结
The purpose of this study is to collect and compare the heart's electrical activity data measured by the novel Conduction System Pacing (CSP) Display Research System with data measured via 12 lead electrocardiogram (ECG) from a commercially available, standard of care electro-physiology (EP) monitoring and recording device during the pacemaker implantation. Participants receiving a routine de-novo implantation of a pacemaker for left bundle branch area pacing (LBBAP) will undergo the CSP Display System protocol during the implant procedure.
详细描述
This feasibility study evaluates the use of the CSP Display Research System during single- or dual-chamber pacemaker implantation for left bundle branch area pacing (LBBAP). The system provides visualization of electrocardiogram data and automatic measurement of left ventricular activation time. Measurements using the CSP Display Research System will be compared with measurements obtained from a standard electrophysiology (EP) recording system used during the implant procedure as part of standard clinical practice. This study also includes exploratory collection of electrocardiogram, intracardiac electrogram, pacemaker marker channel, and left ventricular activation time data during the implant procedure to support future research and algorithm development. These data will be collected for exploratory purposes and do not have a pre-specified evaluation in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subject is at least 18 years of age
- •Subject is willing and able to provide written informed consent
- •Subject is willing and able to comply with the protocol
- •Subject meets eligibility for de-novo implant of a pacemaker (single or dual chamber) with left bundle branch area pacing (LBBAP) therapy
排除标准
- •Subject is not available to comply with visit schedule
- •Pregnant or breastfeeding woman (pregnancy test required for woman of child-bearing potential and who are not on a reliable form of birth regulation method or abstinence)
- •Subject is currently enrolled or planning to enroll in a concurrent study that may confound the results of this study. Pre-approval from the study manager is required for enrollment of a patient that is in a concurrent study.
- •Subject meets any exclusion criteria required by local law
- •Vulnerable adults (i.e. subjects incapable of giving consent)
结局指标
主要结局
Left Ventricular Activation Time (LVAT)
时间窗: During pacemaker implant procedure
LVAT measured using the CSP Display Research System and a commercial electrophysiology recording system
次要结局
- Surface ECG V1 morphology(During pacemaker implant procedure)