Registry of His Bundle, Bachmann Bundle and Left Bundle Branch Area Pacing for Various Pacing Indications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Acute and long-term implant success rate
研究概览
简要总结
The aim of this study is to evaluate safety and clinical outcomes after different pacing approaches of conduction system pacing in a prospective registry.
详细描述
In comparison with right ventricular pacing-induced electromechanical dyssynchrony, conduction system pacing is providing physiological pacing via His-Purkinje activation. Current approaches include His bundle (HBP), left bundle branch area pacing (LBBAP), and Bachmann bundle pacing. In addition, HBP and LBBAP enable correction of underlying proximal bundle branch block, consequently improving the ventricular activation time and narrowing the QRS. Furthermore, atrial activation can be improved with direct Bachmann bundle stimulation. However, the data regarding long-term performance and safety of these physiological approaches in various clinical scenarios is scarce.
With this registry, the investigators would like to obtain real-world data regarding the feasibility and safety of this physiological pacing approaches in various pacing indications and their implementation in routine clinical practice.
Implant success rate, specific implant characteristics, procedural complications, electrical parameters and clinical outcomes will be analyzed at implantation, 1-3 months after inclusion and every 6 months thereafter. Minimal follow-up will be 2 years.
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
- 5 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Class I and II indications for permanent pacing
- •Atrial fibrillation with uncontrolled ventricular rate for pace and ablate strategy
- •Bundle branch block correction for HF patients
- •Patients with prolonged PR interval and dromotropathy
排除标准
- 未提供
结局指标
主要结局
Acute and long-term implant success rate
时间窗: through study completion, an average of 2 years
Ventricular activation occurring over the conduction system with acceptable pacing threshold
次要结局
- Pacing parameters(peri-procedural)
- Pacing lead stability(through study completion, an average of 2 years)
- Heart failure hospitalisation(through study completion, an average of 2 years)
- Echocardiographic measurements(through study completion, an average of 1 year)
- Procedural characteristics(peri-procedural)
- Stepwise approach of pacing modes(peri-procedural)
研究者
David Žižek, MD, PhD
Head of electro-stimulation program
University Medical Centre Ljubljana