ong term follow-up of the Tendril STS and Isoflex leads in conjunction with the AssurityMRIâ?¢ and Endurity MRIâ?¢ Pacemakers within the 3T MRI Environment - BRADY 3T MRI

Abbott India Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

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•1. Subject must be willing and able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable).
•2. Subject must be implanted with a St. Jude Medical Tendril STS 2088 or Isoflex
•1944/1948 lead, and Assurity MRI or Endurity MRI pacemaker.
•3. Capture threshold is stable and < 2.5V @ 0.5ms at the time of enrollment.
•4. 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
•5. Subject is willing and able to comply with the prescribed follow-up tests and schedule of evaluations.

•1. 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.
•2. The subject is <18 years old (pediatric).
•3. That subject has a life expectancy of less than 12 months due to any condition.
•4. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
•5. 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 clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
•6. Any contraindication to MRI scan, including the presence of additional hardware (e.g. lead extenders, lead adapters, surgical staples, stents, dental braces, or abandoned

发起方

Abbott India Pvt Ltd