NCT00323661

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

COGNITION - Cognitive Performance & Closed Loop Stimulation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 405 (actual)
• Sponsor: Biotronik SE & Co. KG · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cardiac Pacing, Artificial

Interventions

Type	Name	Description
DEVICE	Rate-adaptive pacemaker: accelerometer	Accelerometer based pacing rate adaptation
DEVICE	Rate-adaptive pacemaker: Closed Loop Stimulation	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.

Timeline

• Start date: 2006-05-01
• Primary completion: 2010-11-01
• Completion: 2011-03-01
• First posted: 2006-05-09
• Last updated: 2012-02-13

Locations

55 sites across 10 countries: Australia, Austria, Brazil, Canada, Czechia, Germany, Hong Kong, Israel, Slovakia, Spain