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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
405

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Universitätsklinikum 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
        • Universitätsklinikum Würzburg
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Cognitive performance assessed by the Number Connection Test
Time Frame: 24 months
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biotronik SE & Co. KG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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