Bradycardia Clinical Trial
Official title:
ASSURE MRI Study - Clinical Study to Confirm MRI Safety and Effectiveness Using St. Jude Medical (SJM) Cardiac Rhythm Management Systems
This is a clinical investigational plan (CIP) for the "Clinical Study to Confirm MRI Safety and Effectiveness Using SJM Cardiac Rhythm Management Systems (ASSURE MRI)". This study intends to enroll patients who meet standard bradycardia or tachycardia indications and have already been implanted with one of the SJM device/lead combinations listed in this protocol. The objective of this study is to confirm the safety and effectiveness of each of the four SJM device/lead combinations in an MRI environment. This clinical investigation is sponsored by St. Jude Medical.
This is a prospective, multi-center clinical study designed to confirm the safety and
effectiveness of St. Jude Medical low voltage pacemakers, high voltage dual chamber
Implantable Cardioverter-Defibrillators (ICD), and Cardiac Resynchronization Therapy
Defibrillators (CRT-D) with various leads in an MRI environment.
The study will enroll subjects across multiple geographies and sites. Sites in geographies
where MRI labelling is not yet approved may also be included after appropriate IRB/EC and
local regulatory approvals, as applicable, are obtained. A prospective, multi-center study
design is chosen for generalizability of study results.
The clinical study will be conducted in approximately 40 centers worldwide. Approximately 88
subjects total (with a minimum 22 subjects for each of the four device/lead combinations)
will be enrolled in this study.
Enrollment in the study is expected to take approximately 6-8 months. Subjects will be
followed for 1 month following the MRI scan. The total study duration of the study is
expected to be 10 months, depending on the rate of enrollment.
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