NCT03786640已完成不适用
Long 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 PMCF)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 9
- 主要终点
- Proportion of subjects with a capture threshold increase of ≤ 0.5V at the permanently programmed pulse width
研究概览
简要总结
The objective of this post-market, clinical follow up (PMCF) study, is to confirm the long-term safety of the Tendril STS and Isoflex leads, implanted with the Assurity MRI™ or Endurity MRI™ pacemakers, in patients undergoing a clinically indicated 3T MRI (3 Tesla Magnetic Resonance Imaging) scan.
详细描述
This prospective, non-randomized, observational study will be conducted at 35 centers worldwide where the study devices have 3T MR Conditional labeling; up to 110 patients will be enrolled, and will satisfy the recent PMCF requirement to maintain the CE mark.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Subject must be willing and able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable).
- •Subject must be implanted with a St. Jude Medical Tendril STS 2088 or Isoflex 1944/1948 lead, and Assurity MRI or Endurity MRI pacemaker.
- •Capture threshold is stable and < 2.5V @ 0.5ms at the time of enrollment.
- •Subject is clinically indicated for a 3T MRI scan without sedation NOTE: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the patient can communicate with site personnel during the MRI scan
- •Subject is willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
排除标准
- •The subject is currently participating in a clinical investigation that includes an active treatment arm that may confound the results of this study as determined by Abbott.
- •The subject is <18 years old (pediatric).
- •That subject has a life expectancy of less than 12 months due to any condition.
- •Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
- •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.
- •Any contraindication to MRI scan, including the presence of additional hardware (e.g. lead extenders, lead adapters, surgical staples, stents, dental braces, or abandoned leads).
结局指标
主要结局
Proportion of subjects with a capture threshold increase of ≤ 0.5V at the permanently programmed pulse width
时间窗: from pre- MRI scan to one-month post MRI scan
次要结局
- Proportion of subjects with a sensing amplitude decrease of ≤ 50% from pre-MRI scan to one-month post-MRI scan(from pre-MRI scan to one-month post-MRI scan)
研究者
研究点 (9)
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