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The purpose of this clinical investigation is the continued assessment of the decision accuracy of St. Jude Medical (SJM) ICD with enhanced SVT discriminators in the treatment of subjects with primary and secondary prevention of sudden cardiac death.
With Ellipse™ and Fortify Assura™ ICD family, St. Jude Medical introduced enhanced device algorithms that may be helpful to further improve SVT discrimination success: SecureSense™, Far field morphology, Chamber Onset. These algorithms in combination with a tailored device setting (primary or secondary prevention) will be prospectively investigated within this trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced SVT discriminators | Other | Patients with activated enhanced SVT discriminators (in accordance with predefined mandatory study settings) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICD with enhanced SVT discriminators | Device | ICD will be programmed to uniform device settings with enhanced SVT discrimintators enabled. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inappropriate ICD shocks | Freedom from inappropriate automatically delivered ICD-shocks within 12 months Follow-Up (FU) period after ICD/CRT-D implantation | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| ICD shocks for any reason | Freedom from automatically delivered ICD shocks for any reason during FU period | 12 months |
| Inappropriate ICD therapies | Freedom from automatically delivered inappropriate ICD therapies during FU period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johann C Geller, Prof. Dr. | Zentralklinik Bad Berka | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Estonia Medical Centre | Tallinn | Estonia | ||||
| Tartu University Hospital |
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|
| 12 months |
| Untreated VT/VF | Freedom from untreated sustained ventricular tachycardia (VT) / ventricular fibrillation (VF) during FU period | 12 months |
| Accuracy of ICD therapy decision | Accuracy of ICD therapy decision (VT/VF and nonVT/VF) | 12 months |
| Specificity | Specificity for…
| 12 months |
| Cardiac deaths | Cardiac deaths | 12 months |
| Sensitivity | Sensitivity for sustained VT/VF | 12 months |
| ICD/CRT-D related SAE | ICD/CRT-D related Serious Adverse Events (SAE) | 12 months |
| Tartu |
| Estonia |
| Praxis Dr. med. Bernhardt | Annaberg-Buchholz | 09456 | Germany |
| Zentralklinik Bad Berka GmbH | Bad Berka | 99438 | Germany |
| Hufeland Klinikum GmbH | Bad Langensalza | 99947 | Germany |
| Caritas Krankenhaus | Bad Mergentheim | Germany |
| Medizinisches Versorgungszentrum am Küchwald GmbH | Chemnitz | 09113 | Germany |
| Praxis Dr. med. Stellmach | Chemnitz | 09126 | Germany |
| Klinikum Coburg GmbH | Coburg | Germany |
| Evangelisches Krankenhaus Kalk gGmbH | Cologne | Germany |
| Klinikum Esslingen | Esslingen am Neckar | Germany |
| Universitäts-Herzzentrum Freiburg - Bad Krozingen | Freiburg im Breisgau | Germany |
| Medizinische Hochschule Hannover | Hanover | Germany |
| Oberhavel Kliniken GmbH Klinik Hennigsdorf | Hennigsdorf | Germany |
| Evangelisches Krankenhaus Holzminden gGmbH | Holzminden | 37603 | Germany |
| Praxis Frau Dr. med. Gärtner | Leisnig | Germany |
| Klinikum der Stadt Ludwigshafen am Rhein gGmbH | Ludwigshafen | Germany |
| Klinikum Memmingen | Memmingen | Germany |
| Universitätsklinikum Münster | Münster | Germany |
| Klinikum Oldenburg gGmbH | Oldenburg | 26133 | Germany |
| Christliches Krankenhaus Quakenbrück gGmbH | Quakenbrück | Germany |
| Gem.-Praxis Dres. med. Ebert / Stenzel | Riesa | Germany |
| Hegau-Bodensee-Klinikum mbH | Singen | Germany |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006323 | Heart Arrest |
| D003645 | Death, Sudden |
| D003643 | Death |
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| ID | Term |
|---|---|
| D017147 | Defibrillators, Implantable |
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D004567 | Electrodes, Implanted |
| D019736 | Prostheses and Implants |
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