His Bundle Pacing Device Electrogram Data Collection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Duration of device electrogram
研究概览
简要总结
This is a single-arm, non-randomized, non-blinded study designed to collect device data in patients with permanent His bundle (HB) pacing lead and an existing Abbott permanent pacemaker, defibrillator, or cardiac resynchronization device. Prospective data collection includes surface electrocardiograms, intracardiac electrograms, and pacing parameters, recorded during a patient visit. Additional retrospective data collection includes procedural data during the HB pacing lead and device implant.
Up to 200 subjects will participate in this clinical investigation. The clinical investigation will be conducted at up to 8 centers worldwide.
The total duration of the clinical investigation is expected to be 1 year, including enrollment and data collection from all subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Has previously implanted with Abbott device and any pacing lead at HB
- •Age ≥ 18 years
- •Ability to provide informed consent for study participation
- •Willing to comply with study evaluation requirements
排除标准
- •Suspected pacing system failure
- •Lead impedance out of range
- •Ventricular sensing amplitude lower than 0.5 mV
结局指标
主要结局
Duration of device electrogram
时间窗: through study completion, an average of 1 year
Mean duration of device electrogram during His bundle pacing
Amplitude of device electrogram
时间窗: through study completion, an average of 1 year
Mean amplitude of device electrogram during His bundle pacing
次要结局
未报告次要终点