The purpose of the Evera MRI™ study is to confirm safety and efficacy of the Evera MRI ICD (Implantable cardioverter-defibrillator) System in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans without positioning restrictions (MRI scans may occur anywhere on the body).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
275
Non-diagnostic MRI scans
Waiting period time will equate to 1 hour
MRI-related Events
Number of patients free of MRI-related events. Events include MRI-related complications, sustained tachyarrhythmia, and MRI-related loss of pacing ability.
Time frame: MRI procedure to 1-month post-MRI
Ventricular Pacing Capture Threshold (VPCT)
Number of successful patients, where success is defined as not increasing VPCT by more than 0.5V from pre-MRI/waiting to one month post.
Time frame: Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit
Ventricular Sensing Amplitude (R-wave)
Number of successful patients who do not experience a decrease in ventricular sensing amplitude of \>50% from the pre-MRI/waiting period to the one month post-MRI/waiting period, or a one month post-MRI/waiting value \<3mV accompanied by a decrease of \>25% from the pre-MRI/waiting period to the one month post-MRI/waiting period.
Time frame: Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit
System-related Complications
Number of subjects free of a system-related complication. The system includes the ICD and lead(s) attached to it.
Time frame: Implant to 4 months post-implant
RV Defibrillation Impedance
Number of subjects whose RV defibrillation impedance at the one-month post-MRI/waiting period visit is between 20 and 100 ohms
Time frame: 1-month post-MRI/Waiting Period visit
Superior Vena Cava (SVC) Defibrillation Impedance
Number of subjects whose SVC defibrillation impedance at the one-month post-MRI/waiting period visit is between 20 and 100 ohms
Time frame: 1-month post-MRI/Waiting Period visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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Atrial Pacing Capture Threshold (APCT)
Number of successful patients, where success is defined as not increasing APCT by more than 0.5V from pre-MRI/waiting to one month post.
Time frame: Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit
Atrial Sensing Amplitude
Number of successful patients, where success is defined as not decreasing atrial sensing amplitude by more than 50% from pre-MRI/waiting to one month post.
Time frame: MRI/waiting visit to 1-month post-MRI/Waiting visit