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

Biotronik

Status and phase: Completed; Phase 4

Conditions: Cardiac Pacing, Artificial

Treatments: Device: Rate-adaptive pacemaker: accelerometer; Device: Rate-adaptive pacemaker: Closed Loop Stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00323661

BA079

Details and patient eligibility

About

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.

Full 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.

Enrollment: 405 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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405 participants in 2 patient groups

1

Experimental group

Description:

Rate-adaptation by Closed Loop Stimulation

Treatment:

Device: Rate-adaptive pacemaker: Closed Loop Stimulation

2

Active Comparator group

Description:

Accelerometer based pacing rate adaptation

Treatment:

Device: Rate-adaptive pacemaker: accelerometer