The investigation is designed to provide supporting evidence for the clinical safety of the Biotronik's new Implantable Cardioverter Defibrillator systems when used under specific 3 Tesla MR conditions .
Study Type
OBSERVATIONAL
Enrollment
129
Tachycardia Fast Heart Beat
MRI scan of the head and lower body parts
Flinders Medical Centre
Bedford Park, Australia
Royal North Shore Hospital
Sydney, Australia
Westmead Hospital
Westmead, Australia
Allgemeines Krankenhaus Linz
Serious Adverse Device Effect (SADE)-free rate of implantable cardioverter defibrillators and leads possibly or securely related to the MRI procedure
Time frame: 1 Month
Increase in pacing thresholds ratios measured between 1-month post-MRI and pre-MRI
Evaluate the percentage of ICD leads with an increase in the pacing threshold ratio measured between the Pre-MRI and 1-month post-MRI
Time frame: 1 Month
Decrease in sensing amplitude ratios between 1-month post-MRI and pre-MRI
Evaluate the percentage of ICD leads with a decrease in the sensing amplitude ratio measured between the Pre-MRI and 1-month post-MRI
Time frame: 1 Month
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Linz, Austria
Landesklinikum St. Pölten
Sankt Pölten, Austria
Deutsches Herzzentrum Berlin
Berlin, Germany
Klinikum Coburg
Coburg, Germany
Uniklinikum Düsseldorf
Düsseldorf, Germany
Universitätsklinikum Göttingen
Göttingen, Germany
St. Bonifatius Hospital
Lingen, Germany
...and 2 more locations