NL-OMON49741已完成不适用
ong term follow-up of the Tendril STS and Isoflex leads in conjunction with the Assurity MRI* and Endurity MRI* Pacemakers within the 3T MRI Environment - Brady 3T MRI
Abbott Medical Nederland0 个研究点目标入组 20 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Eligible subjects will meet all of the following:
- •* Are implanted with a St. Jude Medical Assurity MRI or Endurity MRI pacemaker
- •and Tendril STS 2088 or Isoflex 1944/1948 lead
- •* Capture threshold is stable and < 2.5V @ 0.5ms at the time of enrolment
- •* Are clinically indicated to undergo a 3T MRI scan
- •* Are willing and able to provide informed consent for study participation
- •(legal guardian is NOT acceptable).
- •* Are willing and able to comply with the prescribed follow-up tests and
- •schedule of evaluations.
排除标准
- •Subjects will be excluded if they meet any of the following:
- •* Are <18 years old (pediatric)
- •* Are currently participating in a clinical investigation that includes an
- •active treatment arm that may confound the results of this study as determined
- •* Known pregnancy, intends to become pregnant, or the patient is nursing.
- •* Have a life expectancy of less than 12 months due to any condition
- •* Contraindications for having a MRI scan including the presence of metal
- •implants (e.g. stents, dental braces, pumps, hip or knee implants), abandoned
- •or capped leads, or other devices (e.g. DBS).
- •* Presence of other anatomic or comorbid conditions, or other medical, social,
- •or psychological conditions that, in the investigator*s opinion, could limit
- •the subject*s ability to participate in the clinical investigation or to comply
- •with follow-up requirements, or impact the scientific soundness of the clinical
- •investigation results
研究者
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