Comparison of Left Bundle Branch Pacing Versus Conventional Right Ventricular Pacing on AHRE Burden in Patients With Preserved Left Ventricular Ejection Fraction and High Ventricular Pacing Dependency (LBBP-AHRE Trial): A Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 244
- 试验地点
- 1
- 主要终点
- Total cumulative AHRE time for device-detected episodes lasting >6 minutes
研究概览
简要总结
This prospective, randomized controlled trial aims to evaluate the effect of left bundle branch pacing (LBBP) compared with conventional right ventricular (RV) pacing on the cumulative duration (total time) of atrial high-rate episodes (AHREs) in patients with preserved left ventricular ejection fraction (LVEF) who are expected to require frequent ventricular pacing.
Atrial High-Rate Episodes (AHREs) are defined as episodes of atrial tachyarrhythmia that are automatically recorded by device diagnostics and detected by implanted cardiac devices. These episodes usually have an atrial rate ≥170 beats per minute and a duration ≥6 minutes. AHREs are linked to a higher risk of thromboembolic events and clinical atrial fibrillation (AF), and they may indicate subclinical AF or other atrial tachyarrhythmias.
Chronic RV pacing has been linked to mechanical and electrical dyssynchrony, which may encourage atrial remodeling and the development of AF. LBBP provides a more physiological ventricular activation and may reduce atrial tachyarrhythmia time (AHRE time).
Patients with LVEF >50% and atrioventricular (AV) conduction disorders requiring a dual-chamber pacemaker will be randomized to either conventional RV septal pacing or LBBP.
详细描述
This prospective, randomized controlled trial aims to evaluate the effect of left bundle branch pacing (LBBP) compared with conventional right ventricular (RV) pacing on the cumulative duration (total time) of atrial high-rate episodes (AHREs) in patients with preserved left ventricular ejection fraction (LVEF) who are expected to require frequent ventricular pacing.
Atrial High-Rate Episodes (AHREs) are defined as episodes of atrial tachyarrhythmia that are automatically recorded by device diagnostics and detected by implanted cardiac devices. These episodes usually have an atrial rate ≥170 beats per minute and a duration ≥6 minutes. AHREs are linked to a higher risk of thromboembolic events and clinical atrial fibrillation (AF), and they may indicate subclinical AF or other atrial tachyarrhythmias.
Device Algorithm Specificity: AHREs will be validated by reviewing the stored atrial electrograms (EGMs) for a random sample of at least 20% of detected episodes to confirm atrial origin, exclude oversensing, and differentiate atrial tachycardia from atrial fibrillation-like episodes. Device model-specific detection thresholds, including refractory oversensing behavior, atrial blanking periods, and sensitivity parameters, will be documented and standardized across participants where possible.
Chronic RV pacing has been linked to mechanical and electrical dyssynchrony, which may encourage atrial remodeling and the development of AF. LBBP provides a more physiological ventricular activation and may reduce atrial tachyarrhythmia time (AHRE time).
LBBP produces a narrower paced QRS, shorter left ventricular activation time, and more synchronous ventricular contraction compared with RV pacing. These electrophysiologic differences may reduce atrial stretch, left atrial pressure, and atrial substrate remodeling, which are mechanisms believed to lower AHRE burden.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Age ≥ 18 years
- •Scheduled implantation of a dual-chamber pacemaker for:
- •Permanent complete heart block Permanent second-degree AV block (Mobitz II or Mobitz I)
- •Documented preserved LVEF (≥50%)
- •Sinus rhythm at baseline
- •Ability to provide written informed consent
排除标准
- •History of paroxysmal, persistent, or permanent atrial fibrillation
- •Previous atrial fibrillation ablation (catheter-based or surgical)
- •LVEF < 50%
- •Sinus node disease
- •Transient AV block requiring pacemaker implantation
- •Significant structural or valvular heart disease
- •Requirement for pacemaker system upgrade during the study period
- •Requirement for antiarrhythmic therapy for causes other than atrial fibrillation
- •Existing pacemaker or other cardiac device requiring modification for study participation
- •Enrollment in another clinical trial that could interfere with study endpoints or pacing parameters
- •Contraindication to LBBP or associated lead implantation procedure
- •Life expectancy < 12 months
- •Any condition judged by the investigator to compromise participation or the integrity of study data
研究组 & 干预措施
Arm 1: Conventional Right Ventricular Pacing
Procedure: Standard right ventricular septal pacing
Description: Implantation of a dual-chamber pacemaker with the ventricular lead placed in the RV septum.
At follow-up, the ventricular pacing percentage and pacing configuration will be noted.
干预措施: Right Ventricular Pacing (Device)
Arm 2: Left Bundle Branch Pacing (LBBP)
Procedure: Left bundle branch pacing lead implantation
Description: Implantation of a dual-chamber pacemaker with the ventricular lead placed at the left bundle branch area.
Physiological pacing will be programmed into the devices and, at follow-up, the percentage of spontaneous pacing will be noted.
干预措施: Left Bundle Branch Pacing (Device)
结局指标
主要结局
Total cumulative AHRE time for device-detected episodes lasting >6 minutes
时间窗: From pacemaker implantation (or randomization) to 24 months (primary endpoint)
Sum of the durations of all device-detected AHREs with individual episode duration \>6 minutes (atrial rate threshold per device diagnostics, typically ≥170 bpm), expressed as total time (minutes/hours). Total analyzable monitoring time will be defined as the interval from implantation to the last successful device interrogation/remote transmission, excluding periods of missing device data.
次要结局
- Incidence of progression to clinically documented atrial fibrillation (paroxysmal or persistent, symptomatic or asymptomatic, confirmed by ECG, Holter, or wearable monitoring).(From pacemaker implantation (or randomization) to 24 months)
- Total cumulative time in AHRE episodes with individual episode duration 0 to 6 minutes.(From pacemaker implantation (or randomization) to 24 months (primary endpoint))
- Total cumulative time in AHRE episodes with individual episode duration 6 minutes to 6 hours.(From pacemaker implantation (or randomization) to 24 months)
- Total cumulative time in AHRE episodes with individual episode duration 6 hours to 24 hours.(From pacemaker implantation (or randomization) to 24 months)
- Total cumulative time in AHRE episodes with individual episode duration >24 hours.(From pacemaker implantation (or randomization) to 24 months)
- Time to event - for AHRE episodes > 6 min(From pacemaker implantation (or randomization) to 24 months)
- Time to first clinically documented atrial fibrillation.(From pacemaker implantation (or randomization) to 24 months)
- Development of permanent atrial fibrillation.(From pacemaker implantation (or randomization) to 24 months)
- Time to progression to permanent atrial fibrillation.(From pacemaker implantation (or randomization) to 24 months)
- Device- or procedure-related complications (e.g., cardiac perforation, pericardial tamponade, pneumothorax, hemothorax, infection requiring antibiotics or system removal, generator or lead malfunction, hematoma).(From pacemaker implantation (or randomization) to 24 months)
- All-cause mortality.(From pacemaker implantation (or randomization) to 24 months)
- Hospitalization due to AF(From pacemaker implantation (or randomization) to 24 months)
- Hospitalization due to HF(From pacemaker implantation (or randomization) to 24 months)
- Need for cardioversion.(From pacemaker implantation (or randomization) to 24 months)
- Development of pacing-induced cardiomyopathy (PICM)(From pacemaker implantation (or randomization) to 24 months)
- Changes in biomarkers associated with myocardial stress, inflammation, or injury(At baseline and at 12 and 24 months, where available.)
- Changes in structured echocardiographic parameters(At baseline and at 12 and 24 months, where available.)
- Quality-of-life change assessed using a validated questionnaire during follow-up.(At baseline and at 3,6,12,18 and 24 months)
研究者
Georgios Leventopoulos
Assistant Professor of Cardiology - Electrophysiology Patras University Hospital, Greece
University Hospital of Patras