The primary objective of the study is to determine the safety of MRI in patients with non-MRI
conditional pacemakers. The secondary objective is to determine if there are clinically
relevant parameter changes in the devices.
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Full eligibility criteria for NCT02906189
Ages eligible for Study
18 Years to 85 Years
Genders eligible for Study
Accepts Healthy Volunteers
Inclusion Criteria. All patients with non-MRI conditional pacemakers and ICDs between the ages of 18-85 will be eligible to participate. Medical records will be reviewed to confirm the date and make/model of device implanted. Ordering physician discusses the MRI request with radiologist, documenting that there is no appropriate alternate imaging test. Patient must have an appointment with a cardiologist/electrophysiologist prior to MRI. Banner Health policy for standard of care guidelines involving patients receiving MRI's will be followed. Exclusion Criteria. Patients will be excluded from MRI based on the Department of Radiology protocol. Additional
ICD and pacemaker dependent, Pacemaker inserted before 2002, Epicardial leads, fractured leads, abandoned leads, or temporary pacemakers (post-coronary artery bypass graft temporary epicardial pacing wires are acceptable), Patient not awake or unable communicate, Battery voltage at elective replacement interval, implanted non-MRI conditional device (other than pacemaker/ICD).
All locations for NCT02906189
United States (1)
Banner University Medical Center Phoenix
Phoenix, Arizona, United States, 85004
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View full eligibility
Tris trial is registered with FDA with number: NCT02906189. The sponsor of the trial is Banner Health and it is looking for 1500 volunteers for the current phase.
Official trial title: Safety of Magnetic Resonance Imaging in Non-MRI Conditional Pacemakers and ICD Devices
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