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| ID | Type | Description | Link |
|---|---|---|---|
| KEK-ZH Nr 2011/0001/4 | Other Identifier | Zurich University Hospital - Switzerland |
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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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The aim of the study is to characterize and quantify the relative effectiveness and contribution of implantable cardioverter defibrillator (ICD) therapy to the clinical outcomes under the conditions of daily practice.
Swiss, multicenter, prospective, observational study.
The main role of ICD's is to stop potentially lethal ventricular tachyarrhythmias through overdrive pacing or shock, reducing the risk of sudden cardiac death. The device is programmed to detect episodes of arrhythmias, classify them according to the threat to patient, and deliver therapies to stop the arrhythmias.
The actual focus of ICD programming has been the application of fast-pacing therapies (ATP or antitachy pacing) as first therapy before applying a shock as last resort to terminate an episode. Some studies have shown the high success rate of this method in decreasing the number of shock delivered to patients. Furthermore significant improvement has been done to improve the sensitivity and specificity of the detection and discrimination algorithm.
This study will focus on the latest generation of device and their performance will be reviewed and analyzed by an Adjudication Board.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of successful and non successful therapies | First assessment and analysis of therapy efficacy and appropriate detection and classification | 24 months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of device diagnostics alerts and device integrity alerts | First assessment of alerts and classification | 24 months follow up |
| All causes hospitalizations, cardiovascular hospitalizations, death, severe adverse events (SAE) |
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Inclusion Criteria:
Exclusion Criteria:
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ICD patients primary and secondary prevention according to guidelines
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| Name | Affiliation | Role |
|---|---|---|
| Martin Fromer, Professor | CHUV, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland | Principal Investigator |
| Mayella Favre | Medtronic (Suisse) SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital - Basel | Basel | Canton of Basel-City | 4031 | Switzerland | ||
| HFR - Hôpital Cantonal - Fribourg |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 24 months follow up |
| Fribourg |
| Canton of Fribourg |
| 1708 |
| Switzerland |
| HUG - University Hospital Geneva | Geneva | Canton of Geneva | 1211 | Switzerland |
| Kantonsspital St.Gallen | Sankt Gallen | Canton of St. Gallen | 9007 | Switzerland |
| CHUV, Centre Hospitalier Universitaire Vaudois | Lausanne | Canton of Vaud | 1011 | Switzerland |
| GZO Spital - Wetzikon | Wetzikon | Canton of Zurich | 8620 | Switzerland |
| Klinik Im Park - Zurich | Zurich | Canton of Zurich | 8038 | Switzerland |
| Stadtspital TRIEMLI - Zurich | Zurich | Canton of Zurich | 8063 | Switzerland |
| USZ - University Hospital Zurich | Zurich | Canton of Zurich | 8091 | Switzerland |
| CardioCentro Ticino - Lugano | Lugano | Canton Ticino | 6900 | Switzerland |