COGNITION - Cognitive Performance & Closed Loop Stimulation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 405
- 试验地点
- 55
- 主要终点
- Cognitive performance assessed by the Number Connection Test
研究概览
简要总结
The purpose of this study is to compare the influence of accelerometer-based rate adaptation and Closed Loop Stimulation on cognitive performance and quality of life in pacemaker patients.
详细描述
Within the scope of a usual follow-up schedule the influence of the mode of rate-adaptation on cognitive performance of pacemaker patients will be analysed. Accelerometer sensor will be compared with Closed Loop Stimulation over 2 years. The cognitive performance will be measured by means of a standardized psychometric test. The occurrence of atrial fibrillation and serious adverse events, patient self-assessment and quality of life will be evaluated. An analysis of the telemonitored (Home Monitoring) data will be performed in order to identify predictors of changes or differences in cognitive performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a CYLOS pacemaker (implantation within the last 3 to 6 weeks)
- •Closed Loop Stimulation mode activated since pre-hospital discharge
- •Patients with chronotropic incompetence according to physician's judgment
- •Maximum sinus rate < 100 beats per minute (bpm) OR percentage of atrial pacing ≥ 25%
- •Patients suitable for rate-adaptive pacing for at least 2 years
- •Patient informed consent
排除标准
- •Age under 55
- •Pregnant and breast-feeding women
- •Patients who are already enrolled in another study
研究组 & 干预措施
1
Rate-adaptation by Closed Loop Stimulation
干预措施: Rate-adaptive pacemaker: Closed Loop Stimulation (Device)
2
Accelerometer based pacing rate adaptation
干预措施: Rate-adaptive pacemaker: accelerometer (Device)
结局指标
主要结局
Cognitive performance assessed by the Number Connection Test
时间窗: 24 months
次要结局
- self-assessment of general well-being, mental and physical performance assessed by Visual Analogue Scales(12 months and 24 months)
- Home Monitoring data(24 months)
- Quality of life assessed by the SF-08(12 months and 24 months)
- occurrence of atrial fibrillation(12 months and 24 months)
- occurrence of serious adverse events(12 months and 24 months)