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

Biotronik SE & Co. KG405 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

405

Conditions

Cardiac Pacing, Artificial

Interventions

Rate-adaptive pacemaker: accelerometerDEVICE

Accelerometer based pacing rate adaptation

Rate-adaptive pacemaker: Closed Loop StimulationDEVICE

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.

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

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

Locations (55)

Outcomes

Primary Outcomes

Cognitive performance assessed by the Number Connection Test

Time frame: 24 months

Secondary Outcomes

Quality of life assessed by the SF-08

Time frame: 12 months and 24 months

occurrence of atrial fibrillation

Time frame: 12 months and 24 months

occurrence of serious adverse events

Time frame: 12 months and 24 months

self-assessment of general well-being, mental and physical performance assessed by Visual Analogue Scales

Time frame: 12 months and 24 months

Home Monitoring data

Time frame: 24 months

Data from ClinicalTrials.gov

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