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

Study Overview
=================
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.

Official Title
-----------------
COGNITION - Cognitive Performance & Closed Loop Stimulation

Conditions
-----------------
Cardiac Pacing, Artificial

Intervention / Treatment
-----------------
* Device: Rate-adaptive pacemaker: accelerometer
* Device: Rate-adaptive pacemaker: Closed Loop Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Rate-adaptation by Closed Loop Stimulation | Device: Rate-adaptive pacemaker: Closed Loop Stimulation<br>* 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.<br>|
| Active Comparator: 2<br>Accelerometer based pacing rate adaptation | Device: Rate-adaptive pacemaker: accelerometer<br>* Accelerometer based pacing rate adaptation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive performance assessed by the Number Connection Test |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pacing, Rate-adaptive, Quality of life, Cognitive performance, Atrial fibrillation, Pacemaker sensor