Pacing the Octogenarian Plus Population (POPP) A Comparison of Physiologic Versus Ventricular Pacing in Those Who Are 80 Years of Age and Older
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- To determine which pacing mode, physiologic or ventricular, is associated with a reduction in emergency room visits or hospitalizations for cardiovascular/cerebrovascular causes
研究概览
简要总结
Of the 19,000 pacemakers implanted across Canada in 2002, 1/3 of them were for patients 80 years and older. This is the fastest growing segment of our population, yet no study has specifically been done in this age group to determine the optimal pacing mode.
We wish to determine whether dual chamber or single chamber pacing is associated with a reduction in emergency room visits or hospitalizations for cardiovascular causes (e.g., congestive heart failure (CHF), atrial fibrillation (AF)) resulting in improved quality of life.
详细描述
Many patients who are 80 years of age and older, develop AF or CHF. Physiologic pacing has been shown to prevent AF compared to ventricular pacing. Whether prevention of AF and CHF by physiologic pacing reduces emergency room visits or hospitalizations for cardiovascular causes in this population in unknown.
The investigators wish to determine the optimal pacing mode for this patient population that would enable optimal management of cardiovascular problems, resulting in improved quality of life and minimizing use of health care facilities.
Patients recruited to the study will be randomized to either DDDR or VVIR pacing, and followed in the clinic every 6 months for the 3 years of the study.
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
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •80 years of age and older
- •Symptomatic bradycardia
排除标准
- •Permanent atrial fibrillation
- •Previous pacemaker implant
- •Life expectancy less than 1 year
- •Geographic isolation
- •Unable to give informed consent
结局指标
主要结局
To determine which pacing mode, physiologic or ventricular, is associated with a reduction in emergency room visits or hospitalizations for cardiovascular/cerebrovascular causes
时间窗: approximately 3 - 5 years
次要结局
- To determine which pacing mode, physiologic or ventricular, is associated with improved functional capacity and improved quality of life(approximately 3 - 5 years)
研究者
Dr. Anne M. Gillis
Professor of Medicine, University of Calgary
University of Calgary