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This registry is designed to gather further evidence, in addition to the SD01 Master Study, for the safety and efficacy of the SD01 ICD lead.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SD01 ICD lead |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SD01 ICD lead | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| SADE-free rate | 10 years |
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| Measure | Description | Time Frame |
|---|---|---|
| Pacing threshold of SD01 | 3-month follow-up | |
| Sensing amplitude of SD01 | 3-month follow-up | |
| Device deficiencies |
Inclusion Criteria:
Exclusion Criteria:
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Patients with standard ICD/CRT-D (cardiac resynchronization therapy plus defibrillator) indication
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DRK Klinikum Berlin-Köpenick | Berlin | Germany | ||||
| Vivantes Humboldt Klinikum Berlin |
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| ID | Term |
|---|---|
| D014693 | Ventricular Fibrillation |
| D017180 | Tachycardia, Ventricular |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 10 years |
| Long-term pacing impedance, pacing threshold, sensing amplitude and painless shock impedance of SD01 and other leads, if applicable | 10 years |
| Analysis of arrhythmias and their treatment | until 3-month follow-up |
| ICD/CRT-D system performance | 10 years |
| SD01 implantation information, handling and operation time record | Implantation |
| Berlin |
| Germany |
| Universitäres Herzzentrum Hamburg | Hamburg | Germany |
| Klinikum Leverkusen | Leverkusen | Germany |
| University Clinic of Schleswig-Holstein | Lübeck | 23538 | Germany |
| Carl-von-Basedow Klinik | Merseburg | Germany |
| Marienkrankenhaus Papenburg | Papenburg | Germany |
| DRK Krankenhaus Moelln-Ratzeburg | Ratzeburg | Germany |
| SRH Zentralklinikum Suhl | Suhl | Germany |
| Universitätsklinik Würzburg | Würzburg | Germany |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |