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| ID | Type | Description | Link |
|---|---|---|---|
| ITAC06 Eu |
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The aim of the study is to assess the negative predictive value of the T amplitude variance as a method for risk stratification for patients with an increased risk for SCD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ovatio VR 6250 or DR6550 | Device | The study requires the implantation of locally approved material:
Holter recording will be performed with a market approved recording system allowing high resolution ECG recording compatible with the analysis software for TVar. |
| Measure | Description | Time Frame |
|---|---|---|
| TAV score and number of tachyarrhythmic events. | The two phases M0 - M12 and M12 - M24 will be examined separately. For each 12 months period the TAV score at its beginning and tachyarrhythmic events in the following 12 months will be assessed. The NPV will be calculated for both phases. |
| Measure | Description | Time Frame |
|---|---|---|
| TAV change | 12 months of follow up |
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Inclusion Criteria:
Patient has been prescribed the implantation of an SORIN GROUP OvatioTM DR 6550 / VR 6250 system according to relevant currently-approved guidelines
OR
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| BRACHMANN Johannes, PhD | Klinikum Coburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helen Kelle Hospital | Sheffield | Alabama | 35660 | United States | ||
| Valley Regional Arrhytmia Center |
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|
| Tarzana |
| California |
| 91356 |
| United States |
| Piedmont Hospital | Atlanta | Georgia | 30309 | United States |
| CMC - NorthEast | Charlotte | North Carolina | 28025 | United States |
| Northwest Ohio Cardiology Consultants | Toledo | Ohio | 43615 | United States |
| Stafford M. Smith - Scranton Heart Institute | Clarks Green | Pennsylvania | 18411-2326 | United States |
| Easton Cardiology | Easton | Pennsylvania | 18042 | United States |
| Grey-Nuns Hospital | Edmonton | X0C0B0 | Canada |
| Hotel-Dieu du CHUM | Montreal | H2W1T8 | Canada |
| Laval UH, Ste Foy | Québec | G1V4G5 | Canada |
| St. Michael's Hospital | Toronto | M5B1W8 | Canada |
| Herz-und Diabeteszentrum NRW | Bad Oeynhausen | D-32545 | Germany |
| Praxis Westend | Berlin | 10050 | Germany |
| Universitatsklinik Krankenanstalten Bergmannsheil | Bochum | 44789 | Germany |
| Medizinische Universitatsklinik | Bonn | D-53127 | Germany |
| Klinikum | Coburg | 96450 | Germany |
| Landkrankhenhaus Coburg | Coburg | 96450 | Germany |
| Evangelisches Krankenhaus | Düsseldorf | 40217 | Germany |
| Evangelisches Krankhenhaus Düsseldorf | Düsseldorf | 40217 | Germany |
| Kardiocentrum | Frankfurt | 60316 | Germany |
| Kardiocentrum Frankfurt, Klinik Rotes Kreuz | Frankfurt | D-60316 | Germany |
| Städt Klinikum Lüneburg | Lüneburg | 21339 | Germany |
| Johannes Gutenberg-Universitat | Mainz | 55101 | Germany |
| Universitatklinikum Mainz | Mainz | D-55101 | Germany |
| Bogenhausen Städt. Krankenhaus | München | 81925 | Germany |
| Krankenhaus Reinbeck St Adolf-Stift | Reinbeck | 21465 | Germany |
| ST. Adolf Stift; Medizinische Klinik | Reinbek | 21465 | Germany |
| Universitätsklinikum Würzburg | Würzburg | 97080 | Germany |
| Medizinische Klinik und Poliklinik I / kardiologie | Würzburg | D-97080 | Germany |
| Universitario La Fe | Valencia | 46009 | Spain |
| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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