Left Bundle Branch Pacing Versus Conventional Pacing in Patients With Atrioventricular Node Disorders: a Randomized, Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Echocardiographic dyssynchrony index, as expressed with Global Left Ventricular Myocardial Work Efficiency (GWE) (%)
研究概览
简要总结
Recently, the concept of physiological pacing has emerged in the clinical practice, in an attempt to prevent the deteriorating effects of right ventricular pacing in the long-term. Left bundle branch pacing seems to be a safe procedure with promising results that may prevent intraventricular dyssynchony compared with the conventional right ventricular pacing.
详细描述
In this prospective, randomized study the outcomes regarding echocardiographic indices of dyssynchrony in left bundle branch versus conventional right ventricular pacing in patients with atrioventricular node disease will be compared In recent years, His pacing has demonstrated better results regarding resynchronization compared to conventional biventricular pacing in trials of 3D mapping. However, technical difficulties that relate to unstable lead positioning or inability in succeeding low pacing threshold have led to low success rates. An alternative site of physiological pacing that could possibly overcome these issues, while maintaining ventricular synchrony is left bundle branch pacing. The lead implantation of LBB pacing is performed using the Select Secure (3830) pacing lead. The lead is screwed into the interventricular septum, until left bundle branch pacing is achieved. The randomized patients 24 hours after the procedure are echocardiographically evaluated and indices of mechanical dyssynchrony are recorded. Follow-up is conducted at 3 months, 6 months and one year post-procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18 years old
- •Patients with atrioventricular block and EF>50% with a predicted ventricular pacing rate>20%
- •Patients with intraventricular septal diameter>8mm
- •Written informed consent
排除标准
- •Indication for CRT or ICD device
- •Patients with no subclavian approach, who are candidates for leadless devices
- •Presence of severe tricuspid regurgitation
- •Patients who are candidates for implantation from the right side, as currently the provided tools for left bundle branch pacing fascilitate only left sided pacemaker implantations
结局指标
主要结局
Echocardiographic dyssynchrony index, as expressed with Global Left Ventricular Myocardial Work Efficiency (GWE) (%)
时间窗: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the global left ventricular work efficiency- as a measure of dyssynchrony- will be recorded.
次要结局
- B natriuretic peptide measurement (pg/ml)(24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure)
- Procedure Time (min)(1 Day of procedure)
- Dose Area Product (DAP) (cGy/cm2)(1 Day of procedure)
- Implant success(1 Day of procedure)
- Fluoroscopy Time (min)(1 Day of procedure)
- Complications associated with pacemaker implantation(through study completion at 1 year post randomisation)
- Global Work Index (GWI) (mmHg%)(24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure)
- Global Wasted Work (GWW) (mmHg%)(24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure)
- Stroke volume index (SVi) (ml/m2)(24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure)
- Aortic Time- Velocity Integral (TVI) (cm)(24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure)
- Global Longitudinal Strain (GLS) (%)(24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure)
- Segmental CW, WW at the mid septal wall(24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure)
- Segmental CW, WW at the basal lateral wall(24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure)
- Peak Strain Dispersion (PSD) (msec)(24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure)
- Changes in capture threshold (V) in the ventricular lead(24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure)
- Changes in sense (mV) in the ventricular lead(24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure)
- Ejection Fraction (EF) (%)(24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure)
- Left Atrium Strain (%)(24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure)
- Left Atrium Strain Rate (1/s)(24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure)
- Global Constructive Work (GCW) (mmHg%)(24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure)
研究者
Georgios Leventopoulos
Principa Investigator
University Hospital of Patras