A Comparison of Rate Response Performance in Pacemaker Patients With an Indication of Sinus Node Dysfunction.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Arun Rao
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- symptom improvement
研究概览
简要总结
Providing ideal rate response to patients should improve their quality of life and ability to execute activities of daily living.
Medtronic pacemakers provide rate response pacing by utilizing dual zone programming to specify an "activities of daily living" (ADL) response rate and an "exertion" response rate. There is much data to support the target heart rate for an exercise response but the data to support the programming of the ADL rate is lacking.
详细描述
Medtronic pacemakers provide rate response pacing by utilizing dual zone programming to specify an "activities of daily living" (ADL) response rate and an "exertion" response rate. There is much data to support the target heart rate for an exercise response but the data to support the programming of the ADL rate is lacking.
Unpublished Holter data from our center indicates that the ADL rate for most patients in our practice is between 50-70bpm rather than 95bpm. Moreover, this increased ADL rate may impact diastolic filling times and adversely impact cardiac output.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of hypertension
- •Sinus node dysfunction
- •New implantation of a dual chamber pacemaker due to symptomatic sinus dysfunction or chronotropic incompetence defined as exercise heart rate less than 100 beats per minute
排除标准
- •Second or Third degree AV block
- •Age less than 60 or greater than 95 years
- •EF less than 45%
- •Patients that are not ambulatory
- •Persistent atrial fibrillation (atrial fibrillation lasting greater than 7 days)
- •Permanent atrial fibrillation (atrial fibrillation lasting great than 1 year)
结局指标
主要结局
symptom improvement
时间窗: study duration of 9 mths
Patient report symptoms by clinician interview and patient symptom questionnaire
次要结局
- improvement seen on device interrogations and reported improvement of symptoms(study duration of 9 mths)
研究者
Arun Rao
Arun Rao, MD. FACC
Wellmont CVA Heart Institute