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临床试验/NCT07467031
NCT07467031尚未招募不适用

BACHSTIM REGISTRY: a Feasability Prospective Study of Bachmann's Area Pacing

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年4月1日最近更新:
干预措施

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joachim ALEXANDRE

MD

University Hospital, Caen

研究点 (1)

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