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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00323661
First Posted: May 9, 2006
Last Update Posted: February 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biotronik SE & Co. KG
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: COGNITION - Cognitive Performance & Closed Loop Stimulation

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 ]

Secondary Outcome Measures:
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: May 8, 2006
First Posted: May 9, 2006
Last Update Posted: February 13, 2012
Last Verified: February 2012

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