CTRI/2019/04/018796招募中未知
His Bundle Pacing Registry - HBP Registry
St Jude Medical India Pvt Ltd Abbott0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
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
- •Subjects must meet the following inclusion criteria for enrollment in the registry.
- •1. Scheduled for implantation of a de novo Abbott pacemaker, defibrillator, or CRT-P/D device with a pacing lead located at the His bundle according to the clinical siteâ??s routine care
- •2. At least 18 years of age
- •3. Willing and able to comply with the prescribed follow-up tests and schedule of evaluations
- •4. Provided written informed consent prior to any registry-related procedures
排除标准
- •Subjects will be excluded from enrollment if any of the exclusion criteria is met below.
- •1. History of tricuspid valve repair or replacement
- •2. Currently participating in another clinical study with an active treatment arm and belong to the active arm
- •3. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigatorâ??s opinion, could limit the subjectâ??s ability to participate in the registry or to comply with follow-up requirements, or impact the scientific soundness of the registry results
- •4. Previous failed HBP implant
- •5. Life expectancy of less than 6 months
- •6. Known contraindication for an HBP implant (i.e. ongoing infection, known inclusion of the subclavian vein, etc.)
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