CTRI/2011/04/001658已完成4 期
Clinical Outcome of Pacemaker paTIents according to pacing Modality and primary INDications - OPTI-MIND
Guidant Europe a Boston Scientific Company Europe0 个研究点目标入组 1,730 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,730
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. 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.
- •2. 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;
- •3. 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
- •1. Unable to be followed up by the participating centres for a period of two years;
- •2. Current device implanted for more than 15 days;
- •3. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physicians discretion);
- •4. 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.
研究者
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