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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT00323661
First received: May 8, 2006
Last updated: February 10, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Cardiac Pacing, Artificial
 Device: Rate-adaptive pacemaker: accelerometer
Device: Rate-adaptive pacemaker: Closed Loop Stimulation
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: COGNITION - Cognitive Performance & Closed Loop Stimulation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biotronik SE & Co. KG:

Primary Outcome Measures:
  • Cognitive performance assessed by the Number Connection Test [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life assessed by the SF-08 [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: No ]
  • occurrence of atrial fibrillation [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: No ]
  • occurrence of serious adverse events [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: No ]
  • self-assessment of general well-being, mental and physical performance assessed by Visual Analogue Scales [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: No ]
  • Home Monitoring data [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 405
Study Start Date: May 2006
Study Completion Date: March 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Rate-adaptation by Closed Loop Stimulation
 Device: Rate-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.
Active Comparator: 2
Accelerometer based pacing rate adaptation
 Device: Rate-adaptive pacemaker: accelerometer
Accelerometer based pacing rate adaptation

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323661

  Show 55 Study Locations
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
Principal Investigator: Uwe Wiegand, Prof. Dr. Sana-Klinikum Remscheid, 42859 Remscheid, Germany
  More Information

Publications:

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT00323661     History of Changes
Other Study ID Numbers: BA079
Study First Received: May 8, 2006
Last Updated: February 10, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biotronik SE & Co. KG:
Pacing
Rate-adaptive
Quality of life
 Cognitive performance
Atrial fibrillation
Pacemaker sensor

ClinicalTrials.gov processed this record on May 19, 2013