This investigation is designed to provide supporting evidence for the clinical safety of the Ilesto/Iforia ICD (implantable cardioverter-defibrillator)system and the Evia/Entovis HF-T (Heart Failure) triple chamber pacemaker system when used under specific MRI (magnetic resonance imaging) conditions.
Study Type
OBSERVATIONAL
Enrollment
174
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Flinders Medical Center
Bedford Park, South Australia, Australia
The Serious Adverse Device Effect (SADE) -free rate of the ICD/CRT-P system related to MRI
Time frame: pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI
Increase in atrial and ventricular pacing threshold(s) between pre-MRI and 1-month post-MRI
Time frame: pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI
Decrease in P-wave and R-wave amplitude (right and left) between pre-MRI and 1-month post-MRI.
Time frame: pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI
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