NCT00976482已完成不适用
Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,745
- 试验地点
- 1
- 主要终点
- Two-year All-cause Mortality
研究概览
简要总结
The study objective is to collect mid-term clinical outcome in a group of patients implanted with permanent pacemaker (PM) according to real-life clinical practice in a multicenter and international environment.
详细描述
The principal objective of the OPTI-MIND study is to collect data on two-year all-cause mortality in a general population implanted with a PM according to current clinical practice. Additionally, the study aims to stratify the outcome by both known patient-related risk factors and by physiologic pacing mode setting (a specifically defined PM programming). Stratification will be done for pre-specified classes of patients on the basis of their primary rhythm disease.
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 implanted with a current Boston Scientific pacemaker (all ALTRUA models) or any future commercially available Boston Scientific PM families according to international and local guidelines for pacemaker implantation;
- •Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational centre;
- •Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.
排除标准
- •Unable to be followed up by the participating centres for a period of two years;
- •Current device implanted for more than 15 days;
- •Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion);
- •Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry or extensions/amendments of the current protocol. Each instance should be brought to the attention of the sponsor to determine eligibility.
结局指标
主要结局
Two-year All-cause Mortality
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (1)
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