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The purpose of the study is to proof the safety and efficacy of the new ICD sytem (Iforia/Ilesto). The devices are available with DF-1 and DF4 connection. A special focus is set on the ICD system with DF4 connection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICD system with DF4 connection | Iforia/Ilesto ICD with DF4 connection and Linox smart DF4 lead/ Protego |
| |
| ICD system with DF-1 connection | Ilesto/Iforia ICD with DF-1 connection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serious adverse device effect (SADE) rate related to the ICD with DF4 connection | until 3 month follow-up | |
| SADE rate related to the Linox smart DF4 lead (ICD shock lead) | until 3 month follow-up | |
| Shift rate of the painless shock impedance measurement | between 3 and 6 month follow-up | |
| Pacing threshold comparison between Linox smart DF-1 and Linox smart DF4 lead | 3 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of automatic atrial pacing threshold test vs. manual measurement | 3 month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with standard ICD/CRT-D indication who are referred to the hospital.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaetsmedizin Greifswald | Greifswald | Germany |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D014693 | Ventricular Fibrillation |
| D016757 | Death, Sudden, Cardiac |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006323 | Heart Arrest |
| D003645 | Death, Sudden |
| D003643 | Death |