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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICD/CRT-P therapy | Standard indication for ICD or triple-chamber pacemaker therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICD/CRT-P therapy | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The Serious Adverse Device Effect (SADE) -free rate of the ICD/CRT-P system related to MRI | 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 | 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. | pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI |
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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 |
|---|---|---|
| Wolfgang R. Bauer, Prof.Dr.Dr. | Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik I, Oberdürrbacher Str. 6, 97080 Würzburg, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred Hospital | Camperdown | New South Wales | Australia | |||
| Flinders Medical Center |
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| MRI | Other |
|
| Bedford Park |
| South Australia |
| Australia |
| Box Hill Hospital | Box Hill | Victoria | Australia |
| Royal Adelaide Hospital | Adelaide | Australia |
| Royal Perth Hospital | Perth | Australia |
| Royal North Shore Hospital | Sydney | Australia |
| AKH Linz | Linz | Austria |
| Landesklinikum St. Pölten | Sankt Pölten | 3100 | Austria |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada |
| Toronto General Hospital | Toronto | Ontario | Canada |
| Montreal Heart Institute | Montreal | Quebec | Canada |
| CHUS - Centre hospitalier universitaire de Sherbrooke | Sherbrooke | Quebec | Canada |
| Royal Alexandra Hospital | Edmonton | Canada |
| University Hospital Olomouc | Olomouc | Czechia |
| CHU Brest | Brest | France |
| CHRU de Tours - Hopital Trousseau | Tours | France |
| Universitätsklinikum Bonn | Bonn | 53105 | Germany |
| Klinikum Coburg | Coburg | Germany |
| Elisabeth Krankenhaus Essen | Essen | 45138 | Germany |
| Schwarzwald Baar Klinikum Villingen Schwenningen | Villingen-Schwenningen | 78050 | Germany |
| Medizinische Universitätsklinik Würzburg | Würzburg | 97080 | Germany |
| Semmelweis University | Budapest | 1122 | Hungary |
| Stadtspital Triemli | Zurich | Switzerland |