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.
Study Type
OBSERVATIONAL
Enrollment
1,768
pacemaker, leads
Freedom from Tendril MRI RA lead-related complications through 60 months of follow up
Time frame: 60 months
Freedom from Tendril MRI RV lead-related complications through 60 months of follow up
Time frame: 60 months
MRI scan related complications rate through one-month following the MRI scan
Time frame: 1 month
The complication rate of the Tendril MRI lead
Time frame: 60 months
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