Cardiac Pacing, Artificial Clinical Trial
— COGNITIONOfficial title:
COGNITION - Cognitive Performance & Closed Loop Stimulation
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.
Status | Completed |
Enrollment | 405 |
Est. completion date | March 2011 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 55 Years and older |
Eligibility |
Inclusion Criteria: - Patients with a CYLOS pacemaker (implantation within the last 3 to 6 weeks) - Closed Loop Stimulation mode activated since pre-hospital discharge - Patients with chronotropic incompetence according to physician's judgment - Maximum sinus rate < 100 beats per minute (bpm) OR percentage of atrial pacing = 25% - Patients suitable for rate-adaptive pacing for at least 2 years - Patient informed consent Exclusion Criteria: - Age under 55 - Pregnant and breast-feeding women - Patients who are already enrolled in another study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Sydney Adventist Hospital | Sydney | |
Austria | A.ö. Krankenhaus der Stadt Linz | Linz | |
Austria | Krankenhaus der Barmherzigen Schwestern Ried | Ried | |
Austria | A. ö. Landeskrankenhaus Steyr | Steyr | |
Austria | Wilhelminenspital der Stadt Wien | Wien | |
Brazil | Hospital Anchieta, Instituto do Coracao de Taguatinga | Brasilia - DF | |
Brazil | Hospital Sao Francisco | Porto Alegre | |
Brazil | Hospital Real e Benemerita Sociedade Portuguesa de Beneficencia | Sao Paulo | |
Canada | Practice Dr. Bloomberg | Burnaby, B.C. | |
Canada | Kelowna Cardiology Research | Kelowna BC | |
Canada | Hopital Sacre-Coeur | Montreal | |
Canada | Dr. Dante Manyauri | Surrey BC | |
Canada | Scarborough Cardiology Research | Toronto, Ontario | |
Czech Republic | Fakultni Nemocnice u Svety Anny | Brno | |
Germany | Universitätsklinik der RWTH Aachen | Aachen | |
Germany | Städtische Kliniken Bielefeld, Klinikum Mitte | Bielefeld | |
Germany | St. Agnes Hospital GmbH, 1. Medizinische Klinik-Kardiologie | Bocholt | |
Germany | Klinikum Coburg | Coburg | |
Germany | Klinikum Lippe-Detmold | Detmold | |
Germany | Med. Klinik/Kardiologie, Herzzentrum, Universitätsklinik an der Technischen Universität Dresden | Dresden | |
Germany | Kreisklinik Ebersberg GmbH | Ebersberg | |
Germany | Marien-Hospital Erftstadt-Frauenthal | Erftstadt-Frauenthal | |
Germany | Klinken Erlabrunn GmbH | Erlabrunn | |
Germany | Westdeutsches Herzzentrum Essen; Klinik für Kardiologie und Thorax-Kardiovaskuläre Chirurgie des Universitätsklinikums Essen | Essen | |
Germany | Kardiologisches Zentrum am Zoo | Frankfurt | |
Germany | St. Elisabeth-Hospital | Gütersloh | |
Germany | Klinikum der Medizinischen Fakultät Halle-Wittenberg | Halle | |
Germany | AK Altona | Hamburg | |
Germany | Universitätsklinikum Hamburg-Eppendorf | Hamburg | |
Germany | Zentrum für Kardiologische und Angiologische Medizin Hamburg | Hamburg | |
Germany | St. Vinzenz-Krankenhaus Hanau gGmbH | Hanau | |
Germany | Medizinische Hochschule Hannover | Hannover | |
Germany | Universitätsklinikum Heidelberg | Heidelberg | |
Germany | Klinikum Herford | Herford | |
Germany | Evangelisches Krankenhaus Holzminden | Holzminden | |
Germany | Klinikum der Universität Jena Klinik für Innere Medizin I | Jena | |
Germany | Kardiologische Gemeinschaftspraxis | Kiel | |
Germany | Städtisches Klinikum St. Georg | Leipzig | |
Germany | Universitätsklinikum Lübeck | Lübeck | |
Germany | Krankenhaus St. Franziskus, Medizinische Klinik II | Mönchengladbach | |
Germany | St. Vincenz-Krankenhaus GmbH | Paderborn | |
Germany | Kardiologische Praxis | Papenburg | |
Germany | Christl. Krankenhaus Quakenbrück | Quakenbrück | |
Germany | Elisabeth Krankenhaus GmbH | Recklinghausen | |
Germany | St. Adolf-Stift | Reinbek | |
Germany | Gemeinschaftspraxis Dr. Stenzel/Dr. Ebert | Riesa | |
Germany | Evangelisches Elisabeth Krankenhaus | Trier | |
Germany | Gemeinschaftspraxis Drs. Schley, Burkhard-Meier, Schemeitat | Viersen | |
Germany | Universitätsklinikum Würzburg | Würzburg | |
Hong Kong | Princess Margaret Hospital | Hong Kong | |
Hong Kong | Yan Chai Hospital | Hong Kong | |
Israel | Wolfson Medical Center | Holon | |
Slovakia | Nemocnica Ministerstva Obrany | Bratislava | |
Slovakia | VUSCH East Slovak Cardiology Institute, Arytmology | Kosice | |
Spain | Hospital Universitario La Fé | Valencia |
Lead Sponsor | Collaborator |
---|---|
Biotronik SE & Co. KG |
Australia, Austria, Brazil, Canada, Czech Republic, Germany, Hong Kong, Israel, Slovakia, Spain,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cognitive performance assessed by the Number Connection Test | 24 months | No | |
Secondary | Quality of life assessed by the SF-08 | 12 months and 24 months | No | |
Secondary | occurrence of atrial fibrillation | 12 months and 24 months | No | |
Secondary | occurrence of serious adverse events | 12 months and 24 months | No | |
Secondary | self-assessment of general well-being, mental and physical performance assessed by Visual Analogue Scales | 12 months and 24 months | No | |
Secondary | Home Monitoring data | 24 months | No |
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