Conduction System Pacing International Registry (CONSPIRE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 383
- 试验地点
- 8
- 主要终点
- QRS duration measured by electrocardiography after implant
研究概览
简要总结
The purpose of this registry study is to collect information about routine clinical practices with device implantation to treat bradycardia and cardiac systolic dysfunction (heart rhythm disorders) across global centers of excellence in cardiac pacing. In particular, this study will examine the use of conduction system pacing (CSP) in clinical practice. Information collected in the registry will help researchers better characterize strengths and limitations of current technology and treatments.
详细描述
During this past decade, there has been a dramatic surge in interest in new physiologic pacing strategies which engage and take advantage of the intrinsic cardiac conduction system. These approaches include His bundle pacing (HBP) as well as approaches which seek to pace the proximal left conduction system (LCS), including left bundle branch area pacing (LBBAP) or pacing in the region of the left posterior fascicle. Left ventricular septal pacing (LVS) has also been proposed as another means to avoid dyssynchrony with early data suggestive of comparable electrical synchronization as biventricular pacing. These approaches utilize approved pacing systems and leads which are delivered to new targets in the His-Purkinje system or LV endocardial fibers. Despite the growing interest in HBP, LCS, and LVS, the majority of data are from disparate cohort studies and there has been a lack of uniformity in assembling data or analyzing and interpreting outcomes.
The goal of the Conduction System Pacing International Registry (CONSPIRE) is to systematically and prospectively collect data across multiple centers of excellence on the early implementation of permanent conduction system pacing devices in order to characterize strengths and limitations of current technology. The study will evaluate patient selection, intraprocedural characteristics, and clinical outcomes among patients receiving conduction system pacing (CSP) as part of their routine clinical care.
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
- •Meets American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Rhythm Society (HRS) guidelines for bradycardia, or
- •Meets ACC/AHA/HRS guidelines for cardiac resynchronization therapy (CRT).
排除标准
- •Age < 18 years
- •Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity
- •Pregnancy
- •Difficulty with follow-up
研究组 & 干预措施
Individuals receiving conduction system pacing
干预措施: Data collection (Other)
结局指标
主要结局
QRS duration measured by electrocardiography after implant
时间窗: Month 0, pre discharge
Data will be collected on QRS duration (milliseconds) after implant procedure
QRS morphology captured by surface electrocardiography after implant
时间窗: Month 0, pre discharge
Data will be collected on QRS morphology \[e.g., narrow QRS, left bundaloid QRS in V1, or right bundaloid QRS in V1\] after implant procedure
Sustained ventricular arrhythmia occurrences
时间窗: Through 12 months
Data will be collected to characterize sustained ventricular arrhythmia occurrences
Implant characteristics
时间窗: Month 0, during procedure
Data will be collected on CSP lead position based on reported anatomical position (e.g., His bundle location, left bundle branch area or left bundle branch pacing location, or left ventricular septal pacing location)
QRS duration measured by electrocardiography at baseline
时间窗: Baseline, within 1 month prior to procedure
Data will be collected on QRS duration (milliseconds) prior to implant
Procedure-related complications
时间窗: Through 12 months
Data will be collected to characterize procedure-related complications
Changes in chamber dimension
时间窗: Through 12 months
Data will be collected to characterize changes in chamber dimension
Any-cause mortalities
时间窗: Through 12 months
Data will be collected to characterize any-cause mortalities within the first 12 months after device implant
System-related complications
时间窗: Through 12 months
Data will be collected to characterize system-related complications
Changes in left ventricular ejection fraction
时间窗: Through 12 months
Data will be collected to characterize changes in left ventricular ejection fraction
QRS morphology captured by surface electrocardiography at baseline
时间窗: Baseline, within 1 month prior to procedure
Data will be collected on QRS morphology (e.g., narrow QRS, left bundle branch block, right bundle branch block, left anterior or posterior hemiblock, nonspecific intraventricular conduction delay, or predominantly paced QRS) prior to implant
Heart failure hospitalizations
时间窗: Through 12 months
Data will be collected to characterize heart failure hospitalizations within the first 12 months after device implant
Lead-related complications
时间窗: Through 12 months
Data will be collected to characterize lead-related complications
次要结局
未报告次要终点