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The purpose of this study is to compare the influence of accelerometer-based rate adaptation and Closed Loop Stimulation on cognitive performance and quality of life in pacemaker patients.
Within the scope of a usual follow-up schedule the influence of the mode of rate-adaptation on cognitive performance of pacemaker patients will be analysed. Accelerometer sensor will be compared with Closed Loop Stimulation over 2 years. The cognitive performance will be measured by means of a standardized psychometric test. The occurrence of atrial fibrillation and serious adverse events, patient self-assessment and quality of life will be evaluated. An analysis of the telemonitored (Home Monitoring) data will be performed in order to identify predictors of changes or differences in cognitive performance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Rate-adaptation by Closed Loop Stimulation |
|
| 2 | Active Comparator | Accelerometer based pacing rate adaptation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rate-adaptive pacemaker: accelerometer | Device | Accelerometer based pacing rate adaptation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive performance assessed by the Number Connection Test | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life assessed by the SF-08 | 12 months and 24 months | |
| occurrence of atrial fibrillation | 12 months and 24 months | |
| occurrence of serious adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Uwe Wiegand, Prof. Dr. | Sana-Klinikum Remscheid, 42859 Remscheid, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sydney Adventist Hospital | Sydney | NSW 2076 | Australia | |||
| A.ö. Krankenhaus der Stadt Linz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18507543 | Background | Wiegand U, Nuernberg M, Maier SK, Weiss C, Sancho-Tello MJ, Hartmann A, Schuchert A, Maier P, Chan NY. The COGNITION study rationale and design: influence of closed loop stimulation on cognitive performance in pacemaker patients. Pacing Clin Electrophysiol. 2008 Jun;31(6):709-13. doi: 10.1111/j.1540-8159.2008.01075.x. |
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| Rate-adaptive pacemaker: Closed Loop Stimulation |
| Device |
Closed Loop Stimulation (CLS) is a unique concept in rate-adaptive pacing that uses the natural cardiovascular control loop to determine the appropriate pacing rate. Closed Loop Stimulation is the only rate-adaptive system responding to mental stress and thereby assuring optimal cerebral perfusion in everyday activity. |
|
| 12 months and 24 months |
| self-assessment of general well-being, mental and physical performance assessed by Visual Analogue Scales | 12 months and 24 months |
| Home Monitoring data | 24 months |
| Linz |
| 4020 |
| Austria |
| Krankenhaus der Barmherzigen Schwestern Ried | Ried | 4910 | Austria |
| A. ö. Landeskrankenhaus Steyr | Steyr | 4400 | Austria |
| Wilhelminenspital der Stadt Wien | Vienna | 1160 | Austria |
| Hospital Anchieta, Instituto do Coracao de Taguatinga | Brasilia - DF | 71525-255 | Brazil |
| Hospital Sao Francisco | Porto Alegre | 90510-000 | Brazil |
| Hospital Real e Benemerita Sociedade Portuguesa de Beneficencia | São Paulo | 01323-001 | Brazil |
| Practice Dr. Bloomberg | Burnaby, B.C. | V5H 2E3 | Canada |
| Kelowna Cardiology Research | Kelowna BC | V1Y 1E4 | Canada |
| Hopital Sacre-Coeur | Montreal | H4J 1C5 | Canada |
| Dr. Dante Manyauri | Surrey BC | V3V 1N1 | Canada |
| Scarborough Cardiology Research | Toronto, Ontario | M1P 2T7 | Canada |
| Fakultni Nemocnice u Svety Anny | Brno | 65691 | Czechia |
| Universitätsklinik der RWTH Aachen | Aachen | 52074 | Germany |
| Städtische Kliniken Bielefeld, Klinikum Mitte | Bielefeld | 33604 | Germany |
| St. Agnes Hospital GmbH, 1. Medizinische Klinik-Kardiologie | Bocholt | 46397 | Germany |
| Klinikum Coburg | Coburg | 96450 | Germany |
| Klinikum Lippe-Detmold | Detmold | 32756 | Germany |
| Med. Klinik/Kardiologie, Herzzentrum, Universitätsklinik an der Technischen Universität Dresden | Dresden | 01307 | Germany |
| Kreisklinik Ebersberg GmbH | Ebersberg | 85560 | Germany |
| Marien-Hospital Erftstadt-Frauenthal | Erftstadt-Frauenthal | 50374 | Germany |
| Klinken Erlabrunn GmbH | Erlabrunn | 08349 | Germany |
| Westdeutsches Herzzentrum Essen; Klinik für Kardiologie und Thorax-Kardiovaskuläre Chirurgie des Universitätsklinikums Essen | Essen | 45122 | Germany |
| Kardiologisches Zentrum am Zoo | Frankfurt | 60316 | Germany |
| St. Elisabeth-Hospital | Gütersloh | 33276 | Germany |
| Klinikum der Medizinischen Fakultät Halle-Wittenberg | Halle | 06120 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Zentrum für Kardiologische und Angiologische Medizin Hamburg | Hamburg | 22041 | Germany |
| AK Altona | Hamburg | 22763 | Germany |
| St. Vinzenz-Krankenhaus Hanau gGmbH | Hanau | 63450 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Klinikum Herford | Herford | 32049 | Germany |
| Evangelisches Krankenhaus Holzminden | Holzminden | 37603 | Germany |
| Klinikum der Universität Jena Klinik für Innere Medizin I | Jena | 07743 | Germany |
| Kardiologische Gemeinschaftspraxis | Kiel | 24116 | Germany |
| Städtisches Klinikum St. Georg | Leipzig | 04129 | Germany |
| Universitätsklinikum Lübeck | Lübeck | 23538 | Germany |
| Krankenhaus St. Franziskus, Medizinische Klinik II | Mönchengladbach | 41063 | Germany |
| St. Vincenz-Krankenhaus GmbH | Paderborn | 33098 | Germany |
| Kardiologische Praxis | Papenburg | 26871 | Germany |
| Christl. Krankenhaus Quakenbrück | Quakenbrück | 49610 | Germany |
| Elisabeth Krankenhaus GmbH | Recklinghausen | 45661 | Germany |
| St. Adolf-Stift | Reinbek | 21465 | Germany |
| Gemeinschaftspraxis Dr. Stenzel/Dr. Ebert | Riesa | 01587 | Germany |
| Evangelisches Elisabeth Krankenhaus | Trier | 54292 | Germany |
| Gemeinschaftspraxis Drs. Schley, Burkhard-Meier, Schemeitat | Viersen | 41747 | Germany |
| Universitätsklinikum Würzburg | Würzburg | 97080 | Germany |
| Princess Margaret Hospital | Hong Kong | Hong Kong |
| Yan Chai Hospital | Hong Kong | Hong Kong |
| Wolfson Medical Center | Holon | 58100 | Israel |
| Nemocnica Ministerstva Obrany | Bratislava | 83331 | Slovakia |
| VUSCH East Slovak Cardiology Institute, Arytmology | Košice | 04011 | Slovakia |
| Hospital Universitario La Fé | Valencia | E-46009 | Spain |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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