Last updated on May 2019

SJM Brady MRI Post Approval Study


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Bradycardia
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Subject is able to provide informed consent for study participation (legally authorized representative is NOT acceptable).
  2. Subject is at least 18 years of age or of legal age to give informed consent specific to state and national law.
  3. Subject meets at least one of the following criteria:
  4. Is an Accent MRI IDE study subject who is being rolled over into the SJM Brady MRI PAS and still has at least one Tendril MRI lead implanted with a SJM Brady MRI pacemaker such as the Accent MRI or similar model.
  5. Is a subject who has been implanted with at least one Tendril MRI lead and a SJM Brady MRI pacemaker such as the Accent MRI or similar model, but is not part of the Accent MRI IDE study and will be enrolled within 30 days after implant.
  6. Is a subject who will be implanted with at least one Tendril MRI lead and a SJM Brady MRI pacemaker such as the Accent MRI or similar model and will be consented either at or within 30 days before implant.
  7. Subject is willing and able to comply with the prescribed follow-up tests and schedule of evaluations including MRI scan procedures.

Exclusion Criteria:

  1. Subject has been enrolled or intends to participate in a clinical drug and/or device study with an active treatment arm or that has any procedures, which could confound the results of this trial.
  2. Subject is not expected to be able to complete the study follow up schedule or duration due to any health condition such as has malignancy, is deemed a candidate for transplant or Ventricular Assist Device, or in hospice care.

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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