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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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The goal of APART is the assessment of the therapeutic and preventive stimulation algorithms of the Medtronic AT500 and following devices in patients with atrial tachyarrhythmias and an indication for cardiac pacing according to the German guidelines. Medication is controlled throughout the study with a beta-blocker as the only antiarrhythmic drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | No Intervention | Algorithms for prevention and termination of AF not activated | |
| Prevention and Therapy Algorithms on | Active Comparator | Activation of preventive and therapeutic algorithms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activation of preventive and therapeutic algorithms for treatment of AF | Device | Algorithms in At 500 or Enrhyhtm for prevention and termination of Atrial Fibrillation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of symptomatic and/or persistent re-occurrences of atrial arrhythmias | 2 years | |
| Time to first re-occurrence of first symptomatic or persistent atrial arrhythmia | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial fibrillation (AF)-burden | 2 years | |
| Time interval between persistent episodes during the follow-up period | 2 years | |
| Reduction of the total amount of tachyarrhythmias stored in the event counter of the implanted device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Uwe Wiegand, MD | Universitätsklinik Lübeck Schleswig-Holstein, Campus Lübeck | Principal Investigator |
| Christian Wolpert, MD | Universitätsklinik Mannheim | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Segeberger Kliniken | Bad Segeberg | 23795 | Germany | |||
| Kath. Krankenhausgemeinschaft GmbH, Philippusstift Essen |
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| AF Prevention and Therapy Algorithms On | Device | Activation of AF-prevention and termination algorithms in AT 500 or EnRhyhtm |
|
| 2 years |
| Quality of life | 2 years |
| Necessity and date of a specific antiarrhythmic therapy and/or prescription of antiarrhythmic drugs class I and II | 2 years |
| Evaluation of possible atrial proarrhythmic effects of the termination algorithms | 2 years |
| Cost-efficiency | 2 years |
| Incidence in different pacing modes [AAI, DDD(R)] | 2 years |
| Essen |
| 45355 |
| Germany |
| Krankenhaus Marienhof | Koblenz | 56056 | Germany |
| Klinikum der Stadt Ludwigshafen | Ludwigshafen | 67063 | Germany |
| Universitätsklinik Lübeck Schleswig-Holstein, Campus Lübeck | Lübeck | 23538 | Germany |
| Universitätsklinik Mannheim | Mannheim | 68167 | Germany |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| 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 |
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