Cardiac Pacing, Artificial
Conditions
Keywords
Pacing, Rate-adaptive, Quality of life, Cognitive performance, Atrial fibrillation, Pacemaker sensor
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.
Interventions
DEVICERate-adaptive pacemaker: accelerometer
Accelerometer based pacing rate adaptation
DEVICERate-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.
Sponsors
Biotronik SE & Co. KG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive performance assessed by the Number Connection Test | 24 months |
Secondary
| Measure | 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 | 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 |
Countries
Australia, Austria, Brazil, Canada, Czechia, Germany, Hong Kong, Israel, Slovakia, Spain
Outcome results
None listed