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Closed Loop Stimulation, Cognitive Performance, and Quality of Life in Pacemaker Patients — COGNITION  

Cardiac Pacing, Artificial Clinical Trial

Official title:
COGNITION - Cognitive Performance & Closed Loop Stimulation

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00323661
Study type Interventional
Source Biotronik SE & Co. KG
Contact
Status Completed
Phase Phase 4
Start date May 2006
Completion date March 2011
View Details
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