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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 .
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantable Cardioverter Defibrillator therapy | Device | Tachycardia Fast Heart Beat | ||
| Magnetic Resonance Imaging (MRI) | Other | MRI scan of the head and lower body parts |
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Device Effect (SADE)-free rate of implantable cardioverter defibrillators and leads possibly or securely related to the MRI procedure | 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 | 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 | 1 Month |
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Inclusion Criteria:
Exclusion Criteria:
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The patients selected for participation should be from the investigator's general patient population according to the inclusion and exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Rainer Zbinden, Dr. | Triemli Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flinders Medical Centre | Bedford Park | Australia | ||||
| Royal North Shore Hospital |
| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Sydney |
| Australia |
| Westmead Hospital | Westmead | Australia |
| Allgemeines Krankenhaus Linz | 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 |
| National Heart Centre | Singapore | Singapore |
| Stadtspital Triemli | Zurich | Switzerland |