BACHSTIM REGISTRY: a Feasability Prospective Study of Bachmann's Area Pacing
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Success of Bachmann's area pacing
研究概览
简要总结
During pacemaker implantation, the atrial lead is commonly positioned in the right atrium. However, this pacing location can be problematic because it may disrupt physiological atrial activation, leading to atrial dyssynchrony. Such dyssynchrony has been associated with an increased risk of atrial fibrillation and its related complications.
To mitigate atrial dyssynchrony, pacing of the Bachmann's bundle region has emerged as an alternative strategy. Bachmann's bundle is the principal interatrial conduction pathway, and pacing at this site may help preserve physiological atrial activation. Several studies have suggested that pacing in this region can significantly reduce the incidence of new-onset atrial fibrillation and heart failure in selected populations.
To date, however, robust data from large cohorts regarding the feasibility of Bachmann's bundle area pacing and the factors associated with successful implantation remain limited. To address this gap, we established the Bachstim cohort study, aimed at determining the success rate of Bachmann's bundle area pacing and identifying the clinical and procedural factors associated with its feasibility.
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
- •Cardiac pacemaker with atrial lead indication
排除标准
- •patients < 18 years old
- •pregnancy of breast feeding
研究组 & 干预措施
Patients with cardiac pace-maker indication and atrial lead indication
干预措施: Bachmann's area pacing (Device)
结局指标
主要结局
Success of Bachmann's area pacing
时间窗: 10 minutes
Successful Bachmann's bundle area pacing is defined by a reduction of the paced P-wave duration by at least 30 ms when the spontaneous P-wave duration exceeds 120 ms, or by a reduction of the paced P-wave duration by at least 10 ms when the spontaneous P-wave duration is ≤120 ms.
次要结局
- Success of Bachmann's area pacing after 3 months follow-up(3 months)
- Success of Bachmann's area pacing after12 months follow-up(12 months)
- AF burden after 12 months follow-up(12 months follow-up)
研究者
Joachim ALEXANDRE
MD
University Hospital, Caen
