ECG Belt to Assess Electrical Synchronization in Patients With Left Bundle Branch Pacing and His-Purkinje Conduction System Optimized Cardiac Resynchronization Therapy (ECG Belt)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- • ECG Belt Analysis of Standard Deviation of Activation Times (SDAT) of LBBP Compared to Native Conduction
研究概览
简要总结
The objective of the study is to assess the utility of ECG Belt to understand the conduction and ECG characteristics of Left Bundle Branch Pacing (LBBAP) and His-Optimized Cardiac Resynchronization Therapy (HOT-CRT) and compare with preexisting data in traditional Cardiac Resynchronization Therapy (CRT) and Right Ventricular Pacing (RVP).
详细描述
The objective of the study is to assess the utility of ECG Belt to understand the conduction and ECG characteristics of LBBP and HOT-CRT and compare with preexisting data in traditional CRT and RVP.
Specific Objective:
- To demonstrate and establish electrical resynchronization using ECG Belt Research System in Left Bundle Branch Pacing (LBBP) and HOT-CRT.
- To assess ECG Belt derived native conduction parameters and compare them to LBBP and HOT-CRT.
- To compare with historic ECG belt parameters obtained for right ventricular pacing/ Biventricular pacing in prior studies.
The ECG Belt study is a prospective, single-center, investigational, pre-market research study. The study team will identify all patients who satisfy the inclusion and exclusion criteria. The study team will evaluate the ECG Belt Research System to assess the electrical characteristics of conduction system pacing in patients with preexisting LBBP or HOT-CRT.
Eligible patients would have successfully undergone LBBP using Medtronic 3830 lead. LBBP will be confirmed at implant using left bundle potentials recorded from the lead, ECG morphology during unipolar and bipolar pacing, peak LV activation time and lead depth in the LV septum by contrast at implant and 2D echo post-implant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patients > 18 years of age
- •Patient has a previously implanted LBBP lead for bradycardia indication or heart failure indication with one of the following at Geisinger within the last 5 years:
- •LBBP+LV lead
- •Patient is willing to comply with all study procedures and be available for the duration of the study.
排除标准
- •Inability to provide informed consent
- •Enrolled in a concurrent study that may confound the results of this study.
结局指标
主要结局
• ECG Belt Analysis of Standard Deviation of Activation Times (SDAT) of LBBP Compared to Native Conduction
时间窗: Visit 1 Baseline-50 minutes
Change in SDAT following LBBP measured in ms using ECG Belt
• ECG Belt Analysis of QRS Duration at Baseline Compared to Various LBBP Options
时间窗: Visit 1 Baseline-50 minutes
Change in QRS duration measured in ms using ECG Belt
• ECG Belt Analysis of RV Dispersion of HOT-CRT Compared to Baseline
时间窗: Visit 1 Baseline- 50 minutes
RV dispersion measured using ECG Belt
• ECG Belt Analysis of Left Ventricular Activations Times (LVAT) of LBBP Compared to Baseline
时间窗: Visit 1 Baseline-50 minutes
Change in LV activation times measured in ms using ECG Belt
• ECG Belt Analysis of LV Dispersion of HOT-CRT Compared to Baseline
时间窗: Visit 1 Baseline- 50 minutes
LV dispersion measured using ECG Belt
次要结局
未报告次要终点
研究者
Pugazhendhi Vijayaraman
Sponsor-Investigator
Geisinger Clinic