SJM-CIP- CL1000304: SJM Brady MRI Post Approval
SJM Brady MRI Post Approval Study
The purpose of this post-approval study is to evaluate the long-term safety of the FDA approved St. Jude Medical Tendril MRI™ lead implanted with a SJM Brady MRI implantable pulse generator (IPG) such as the Accent MRI™, Assurity MRI™, Endurity MRI™ pacemaker, or similar model (SJM Brady MRI System) in subjects with a standard bradycardia pacing indication.
Key Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply.
- Subject is able to provide informed consent for study participation (legally authorized representative is NOT acceptable).
- Subject is at least 18 years of age or of legal age to give informed consent specific to state and national law.
- Subject meets at least one of the following criteria:
- 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.
- 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.
- 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.
- Subject is willing and able to comply with the prescribed follow-up tests and schedule of evaluations including MRI scan procedures.
Key Exclusion Criteria
A patient will not be eligible for participation in this study if any of the following criteria apply.
- 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.
- 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.
To learn more, visit ClinicalTrials.Gov
David Rodak, MD
Abbott Medical Devices