Skip to main content
OpenTrials
Completed

NCT Number: NCT00323661

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiac Pacing, Artificial Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sydney Adventist Hospital, Sydney, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rate-adaptive pacemaker: accelerometer

Device

Accelerometer based pacing rate adaptation

Rate-adaptive pacemaker: Closed Loop Stimulation

Device

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.

Primary outcomes

  1. Cognitive performance assessed by the Number Connection Test

    Time frame: 24 months

Secondary outcomes

  1. Quality of life assessed by the SF-08

    Time frame: 12 months and 24 months

  2. occurrence of atrial fibrillation

    Time frame: 12 months and 24 months

  3. occurrence of serious adverse events

    Time frame: 12 months and 24 months

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

    Time frame: 12 months and 24 months

  5. Home Monitoring data

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

COGNITION - Cognitive Performance & Closed Loop Stimulation

Acronym: COGNITION

Important dates

Study start
2006
Primary completion
2010
Study completion
2011
First posted
May 9, 2006
Registry last updated
Feb 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.