Advanced Bradycardia Device Feature Utilization and Clinical Outcomes II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,101
- 试验地点
- 4
- 主要终点
- Percentage of Participants With Complications in the General Pacemaker Population
研究概览
简要总结
The purpose of this study is to characterize the utilization of diagnostics capabilities in St. Jude Medical pacemakers to manage patients with a standard bradycardia pacing indication.
详细描述
The study is a prospective, non-randomized, multi-center observational study designed to evaluate the utilization of diagnostic capabilities, indications, MRI scanning capabilities and clinical outcomes of patients implanted with SJM pacemakers.
The total duration of the study is expected to be approximately 30 months. The clinical study will be conducted in up to 160 centers across Europe, Middle East, Africa, (EMEA region) and Asia, Australia and New Zealand (Asia-Pac region). Approximately 2016 subjects will be enrolled in this study. Subjects will be followed for 1 year after pacemaker implant.
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
- •Patients who have been implanted with an SJM Assurity MRI™, Endurity MRI™ or other SJM MRI compatible pacemakers in the EMEA region within 30 days or patients implanted with an Accent MRI™, Assurity MRI™, Endurity MRI™ or other SJM MRI compatible pacemakers in the Asia-Pac region within 30 days.
- •Patient is geographically stable and willing to comply with the required follow-up schedule.
- •Patient is not pregnant or planning to become pregnant during the course of the study.
- •Patient is > 18 years of age
排除标准
- •Patient's life expectancy is less than 1 year
结局指标
主要结局
Percentage of Participants With Complications in the General Pacemaker Population
时间窗: 1 year
The rate of device related adverse events that require a medical intervention and/or hospitalization for treatment.
次要结局
- Number of Subjects Programmed With Advanced Pacemaker Features(1 year)
- Number of Pacemaker Patients With Atrial Tachycardia/Fibrillation (AT/AF), Ventricular Tachycardia/Fibrillation (VT/VF), Pacemaker-mediated Tachycardia (PMT) and Automatic Mode Switching (AMS) Episodes(1 year)
- Number of MRI Scans by Country(1 year)