The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI ICD System when used under specific MRI conditions.
Study Type
OBSERVATIONAL
Enrollment
154
Tachycardia Fast Heart Beat
MRI scan of heart/chest or thoracic spine
MRI and ICD System Related Serious Adverse Device Effect (SADE) Free Rate
Time frame: 1 Month Post-MRI
Percentage of Participants Free of Ventricular Pacing Threshold Rise
Evaluate the percentage of ICD leads free of ventricular 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 R-wave Sensing Attenuation
Evaluate the percentage of subjects free of R-wave attenuation between the Pre-MRI and one-month post-MRI follow-up.
Time frame: Between Pre-MRI and 1 Month Post-MRI
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Phoenix, Arizona, United States
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
Valparasio, Indiana, United States
...and 29 more locations