Ignite Creation Date:
2025-12-24 @ 12:11 PM
Ignite Modification Date:
2026-01-09 @ 2:39 AM
Study NCT ID:
NCT00323661
Status:
COMPLETED
Last Update Posted:
2012-02-13
First Post:
2006-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Closed Loop Stimulation, Cognitive Performance, and Quality of Life in Pacemaker Patients
Sponsor:
Biotronik SE & Co. KG
Organization:
Study Overview
Official Title:
COGNITION - Cognitive Performance & Closed Loop Stimulation
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COGNITION
Brief 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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: