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

February 10, 2012 updated by: Biotronik SE & Co. KG

COGNITION - Cognitive Performance & Closed Loop Stimulation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

405

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Sydney, Australia, NSW 2076
        • Sydney Adventist Hospital
  • Austria
      • Linz, Austria, 4020
        • A.ö. Krankenhaus der Stadt Linz
      • Ried, Austria, 4910
        • Krankenhaus der Barmherzigen Schwestern Ried
      • Steyr, Austria, 4400
        • A. ö. Landeskrankenhaus Steyr
      • Wien, Austria, 1160
        • Wilhelminenspital der Stadt Wien
  • Brazil
      • Brasilia - DF, Brazil, 71525-255
        • Hospital Anchieta, Instituto do Coracao de Taguatinga
      • Porto Alegre, Brazil, 90510-000
        • Hospital São Francisco
      • Sao Paulo, Brazil, 01323-001
        • Hospital Real e Benemerita Sociedade Portuguesa de Beneficencia
  • Canada
      • Burnaby, B.C., Canada, V5H 2E3
        • Practice Dr. Bloomberg
      • Kelowna BC, Canada, V1Y 1E4
        • Kelowna Cardiology Research
      • Montreal, Canada, H4J 1C5
        • Hopital Sacre-Coeur
      • Surrey BC, Canada, V3V 1N1
        • Dr. Dante Manyauri
      • Toronto, Ontario, Canada, M1P 2T7
        • Scarborough Cardiology Research
  • Czech Republic
      • Brno, Czech Republic, 65691
        • Fakultni nemocnice u Svety Anny
  • Germany
      • Aachen, Germany, 52074
        • Universitätsklinik der RWTH Aachen
      • Bielefeld, Germany, 33604
        • Städtische Kliniken Bielefeld, Klinikum Mitte
      • Bocholt, Germany, 46397
        • St. Agnes Hospital GmbH, 1. Medizinische Klinik-Kardiologie
      • Coburg, Germany, 96450
        • Klinikum Coburg
      • Detmold, Germany, 32756
        • Klinikum Lippe-Detmold
      • Dresden, Germany, 01307
        • Med. Klinik/Kardiologie, Herzzentrum, Universitätsklinik an der Technischen Universität Dresden
      • Ebersberg, Germany, 85560
        • Kreisklinik Ebersberg GmbH
      • Erftstadt-Frauenthal, Germany, 50374
        • Marien-Hospital Erftstadt-Frauenthal
      • Erlabrunn, Germany, 08349
        • Klinken Erlabrunn GmbH
      • Essen, Germany, 45122
        • Westdeutsches Herzzentrum Essen; Klinik für Kardiologie und Thorax-Kardiovaskuläre Chirurgie des Universitätsklinikums Essen
      • Frankfurt, Germany, 60316
        • Kardiologisches Zentrum am Zoo
      • Gütersloh, Germany, 33276
        • St. Elisabeth-Hospital
      • Halle, Germany, 06120
        • Klinikum der Medizinischen Fakultät Halle-Wittenberg
      • Hamburg, Germany, 20246
        • Universitatsklinikum Hamburg-Eppendorf
      • Hamburg, Germany, 22041
        • Zentrum für Kardiologische und Angiologische Medizin Hamburg
      • Hamburg, Germany, 22763
        • AK Altona
      • Hanau, Germany, 63450
        • St. Vinzenz-Krankenhaus Hanau gGmbH
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany, 69120
        • UniversitatsKlinikum Heidelberg
      • Herford, Germany, 32049
        • Klinikum Herford
      • Holzminden, Germany, 37603
        • Evangelisches Krankenhaus Holzminden
      • Jena, Germany, 07743
        • Klinikum der Universität Jena Klinik für Innere Medizin I
      • Kiel, Germany, 24116
        • Kardiologische Gemeinschaftspraxis
      • Leipzig, Germany, 04129
        • Städtisches Klinikum St. Georg
      • Lübeck, Germany, 23538
        • Universitätsklinikum Lübeck
      • Mönchengladbach, Germany, 41063
        • Krankenhaus St. Franziskus, Medizinische Klinik II
      • Paderborn, Germany, 33098
        • St. Vincenz-Krankenhaus GmbH
      • Papenburg, Germany, 26871
        • Kardiologische Praxis
      • Quakenbrück, Germany, 49610
        • Christl. Krankenhaus Quakenbrück
      • Recklinghausen, Germany, 45661
        • Elisabeth Krankenhaus GmbH
      • Reinbek, Germany, 21465
        • St. Adolf-Stift
      • Riesa, Germany, 01587
        • Gemeinschaftspraxis Dr. Stenzel/Dr. Ebert
      • Trier, Germany, 54292
        • Evangelisches Elisabeth Krankenhaus
      • Viersen, Germany, 41747
        • Gemeinschaftspraxis Drs. Schley, Burkhard-Meier, Schemeitat
      • Würzburg, Germany, 97080
        • Universitatsklinikum Wurzburg
  • Hong Kong
      • Hong Kong, Hong Kong
        • Princess Margaret Hospital
      • Hong Kong, Hong Kong
        • Yan Chai Hospital
  • Israel
      • Holon, Israel, 58100
        • Wolfson Medical Center
  • Slovakia
      • Bratislava, Slovakia, 83331
        • Nemocnica Ministerstva Obrany
      • Kosice, Slovakia, 04011
        • VUSCH East Slovak Cardiology Institute, Arytmology
  • Spain
      • Valencia, Spain, E-46009
        • Hospital Universitario la Fe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cognitive performance assessed by the Number Connection Test
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life assessed by the SF-08
Time Frame: 12 months and 24 months
12 months and 24 months
occurrence of atrial fibrillation
Time Frame: 12 months and 24 months
12 months and 24 months
occurrence of serious adverse events
Time Frame: 12 months and 24 months
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
12 months and 24 months
Home Monitoring data
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik SE & Co. KG

Investigators

  • Principal Investigator: Uwe Wiegand, Prof. Dr., Sana-Klinikum Remscheid, 42859 Remscheid, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

May 8, 2006

First Submitted That Met QC Criteria

May 8, 2006

First Posted (Estimate)

May 9, 2006

Study Record Updates

Last Update Posted (Estimate)

February 13, 2012

Last Update Submitted That Met QC Criteria

February 10, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BA079

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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