NCT00294060终止不适用
Pacemaker Patient Profiling (P3) Study
Medtronic Cardiac Rhythm and Heart Failure0 个研究点目标入组 2,013 人开始时间: 2004年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2,013
- 主要终点
- Number of Participants With Dual Chamber Devices
研究概览
简要总结
The P3 Study is a United States post market study to gather data on clinical status, primary indications, device therapy choices, clinical management and outcomes for patients with implantable pacemakers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patient meets Class I / Class II indications for pacing
- •Patient implanted with one of the following market-approved single or dual chamber Medtronic devices: EnRhythm™, EnPulse®, Kappa® 700, Kappa® 900, Vitatron Clarity™, Vitatron Selection® AFm, Vitatron C-Series, Vitatron T-Series, or the AT500™ DDDR Pacing System
排除标准
- •Patient is enrolled in a device or cardiovascular drug study that affects treatment and/or study device programming
- •Patient whose life expectancy is less than two years
结局指标
主要结局
Number of Participants With Dual Chamber Devices
时间窗: at original implant
Pacemaker device choice characterized by the number of patients with dual chamber devices
Days Hospitalized
时间窗: implant to one year
Healthcare utilization clinical outcome characterized by number of days hospitalized in the first year
Multiple In-clinic Visits
时间窗: implant to one year
Follow-up practice pattern assessed by the number of patients with a dual chamber device that had two or more routine pacemaker in-clinic visits with a device interrogation
次要结局
未报告次要终点
研究者
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