Bradycardia Clinical Trial
Official title:
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.
This is a prospective, multi-center clinical study designed to evaluate the long-term safety
of the Tendril MRI™ lead implanted with any SJM Brady MRI pacemaker or similar model (SJM
Brady MRI system) in subjects with a standard bradycardia pacing indication through 60 months
of follow up.
Additionally, the study will assess the safety of the pacemaker system in subject(s)
undergoing clinically indicated MRI scan(s). Any enrolled subject implanted with the SJM
Brady MRI system may be included in this evaluation if they are scheduled for or planning to
have a MRI scan during the course of the study.
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