The objective of the ProMRI Study (Phase B) is to demonstrate the clinical safety of the ProMRI Pacemaker System when used under specific MRI conditions without scan exclusion zone.
Study Type
OBSERVATIONAL
Enrollment
221
Bradycardia Slow Heart Beat
MRI scan of heart/chest or thoracic spine.
Unnamed facility
Phoenix, Arizona, United States
MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate
Time frame: 1 Month Post-MRI
Percentage of Participants Free of Atrial Pacing Threshold Rise
Evaluate the percentage of atrial pacing leads with a pacing threshold increaess between the Pre-MRI and one-month post-MRI follow-up.
Time frame: Between Pre-MRI and 1 Month Post-MRI
Percentage of Participants Free of Ventricular Pacing Threshold Rise
Evaluate the percentage of ventricular pacing leads with a pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.
Time frame: Between Pre-MRI and 1 Month Post-MRI
Percentage of Participants Free of P-wave Sensing Attenuation
Evaluate the percentage of subjects who experience P-wave attenuation between the pre-MRI and one-month post-MRI follow-up.
Time frame: Between Pre-MRI and 1 Month Post-MRI
Percentage of Participants Free of R-wave Sensing Attenuation
Evaluate the percentage of subjects who experience R-wave attenuation between the pre-MRI and one-month post-MRI follow-up.
Time frame: Between Pre-MRI and 1 Month Post-MRI
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Unnamed facility
Scottsdale, Arizona, United States
Unnamed facility
Concord, California, United States
Unnamed facility
Newport Beach, California, United States
Unnamed facility
Rancho Mirage, California, United States
Unnamed facility
New Haven, Connecticut, United States
Unnamed facility
Newark, Delaware, United States
Unnamed facility
Washington D.C., District of Columbia, United States
Unnamed facility
Valparaiso, Indiana, United States
Unnamed facility
Iowa City, Iowa, United States
...and 22 more locations