Effectiveness of Closed Loop Stimulation (CLS) With His Bundle Lead Placement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in heart rate from baseline to Day 30
研究概览
简要总结
This study is a prospective, non-randomized pilot study looking to evaluate the effectiveness of Closed Loop Stimulation (CLS) in sinus node dysfunction patients with HIS bundle placement. Patients with sinus node dysfunction who have previously received a Biotronik pacemaker with His bundle lead placement as part of routine care will be recruited for the study. A hand-grip exercise will be performed at the conclusion of bicycle exercise testing in order to assess the performance of CLS during isometric exercise. After the study exercise testing is completed, data will be collected from the pacemaker.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented sinus node dysfunction
- •Biotronik pacemaker implanted with His bundle lead placement for standard indications
- •Implanted at least 30 days
- •CLS has been enabled for at least 7 days or will be programmed ON for at least 7 days prior to exercise test
- •Leads and device are functioning appropriately
排除标准
- •Inability to complete treadmill/bicycle exercise test
- •Planned surgical revision or replacement of the device and/or leads
- •Patients who are unwilling or unable to provide informed consent
研究组 & 干预措施
Closed Loop Stimulation (CLS)
Prior to enrollment, the patient would have received Biotronik pacemaker with His bundle lead placement for at least 30 days and CLS will be programmed ON for at least 7 days as part of routine care.
干预措施: Treadmill/Bicycle exercise testing (Diagnostic Test)
结局指标
主要结局
Change in heart rate from baseline to Day 30
时间窗: Day 1, Day 30
Ability to achieve adequate heart rate, defined as reaching upper sensor rate, during peak exertion
次要结局
- Greater heart response with CLS compared to predicted accelerometer based heart rate response(Day 1, Day 30)