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Cardiac Pacing, ArtificialPhase 4COGNITIONNCT00323661

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

A Phase 4 study testing Rate-adaptive pacemaker: accelerometer and Rate-adaptive pacemaker: Closed Loop Stimulation in people with Cardiac Pacing, Artificial, run by Biotronik SE & Co. KG at 55 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Cardiac Pacing, Artificial
What is being tested?
Rate-adaptive pacemaker: accelerometer and Rate-adaptive pacemaker: Closed Loop Stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
405 participants
Where
55 sitesin 10 countries
Study dates
May 2006to Mar 2011
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Age under 55
  • Pregnant and breast-feeding women
  • Patients who are already enrolled in another study

Trial locations and contacts

55 sites in 10 countries.

55 sites in 10 countries

Germany35 sites

  • Universitätsklinik der RWTH Aachen

    Aachen, 52074

  • Städtische Kliniken Bielefeld, Klinikum Mitte

    Bielefeld, 33604

  • St. Agnes Hospital GmbH, 1. Medizinische Klinik-Kardiologie

    Bocholt, 46397

  • Klinikum Coburg

    Coburg, 96450

  • Klinikum Lippe-Detmold

    Detmold, 32756

  • Med. Klinik/Kardiologie, Herzzentrum, Universitätsklinik an der Technischen Universität Dresden

    Dresden, 01307

  • Kreisklinik Ebersberg GmbH

    Ebersberg, 85560

  • Marien-Hospital Erftstadt-Frauenthal

    Erftstadt-Frauenthal, 50374

  • Klinken Erlabrunn GmbH

    Erlabrunn, 08349

  • Westdeutsches Herzzentrum Essen; Klinik für Kardiologie und Thorax-Kardiovaskuläre Chirurgie des Universitätsklinikums Essen

    Essen, 45122

  • Kardiologisches Zentrum am Zoo

    Frankfurt, 60316

  • St. Elisabeth-Hospital

    Gütersloh, 33276

  • Klinikum der Medizinischen Fakultät Halle-Wittenberg

    Halle, 06120

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Zentrum für Kardiologische und Angiologische Medizin Hamburg

    Hamburg, 22041

  • AK Altona

    Hamburg, 22763

  • St. Vinzenz-Krankenhaus Hanau gGmbH

    Hanau, 63450

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Klinikum Herford

    Herford, 32049

  • Evangelisches Krankenhaus Holzminden

    Holzminden, 37603

  • Klinikum der Universität Jena Klinik für Innere Medizin I

    Jena, 07743

  • Kardiologische Gemeinschaftspraxis

    Kiel, 24116

  • Städtisches Klinikum St. Georg

    Leipzig, 04129

  • Universitätsklinikum Lübeck

    Lübeck, 23538

  • Krankenhaus St. Franziskus, Medizinische Klinik II

    Mönchengladbach, 41063

  • St. Vincenz-Krankenhaus GmbH

    Paderborn, 33098

  • Kardiologische Praxis

    Papenburg, 26871

  • Christl. Krankenhaus Quakenbrück

    Quakenbrück, 49610

  • Elisabeth Krankenhaus GmbH

    Recklinghausen, 45661

  • St. Adolf-Stift

    Reinbek, 21465

  • Gemeinschaftspraxis Dr. Stenzel/Dr. Ebert

    Riesa, 01587

  • Evangelisches Elisabeth Krankenhaus

    Trier, 54292

  • Gemeinschaftspraxis Drs. Schley, Burkhard-Meier, Schemeitat

    Viersen, 41747

  • Universitätsklinikum Würzburg

    Würzburg, 97080

Other trials in Germany

Canada5 sites

  • Practice Dr. Bloomberg

    Burnaby, B.C., V5H 2E3

  • Kelowna Cardiology Research

    Kelowna BC, V1Y 1E4

  • Hopital Sacre-Coeur

    Montreal, H4J 1C5

  • Dr. Dante Manyauri

    Surrey BC, V3V 1N1

  • Scarborough Cardiology Research

    Toronto, Ontario, M1P 2T7

Other trials in Canada

Austria4 sites

  • A.ö. Krankenhaus der Stadt Linz

    Linz, 4020

  • Krankenhaus der Barmherzigen Schwestern Ried

    Ried, 4910

  • A. ö. Landeskrankenhaus Steyr

    Steyr, 4400

  • Wilhelminenspital der Stadt Wien

    Vienna, 1160

Other trials in Austria

Brazil3 sites

  • Hospital Anchieta, Instituto do Coracao de Taguatinga

    Brasilia - DF, 71525-255

  • Hospital Sao Francisco

    Porto Alegre, 90510-000

  • Hospital Real e Benemerita Sociedade Portuguesa de Beneficencia

    São Paulo, 01323-001

Other trials in Brazil

Hong Kong2 sites

  • Princess Margaret Hospital

    Hong Kong

  • Yan Chai Hospital

    Hong Kong

Other trials in Hong Kong

Slovakia2 sites

  • Nemocnica Ministerstva Obrany

    Bratislava, 83331

  • VUSCH East Slovak Cardiology Institute, Arytmology

    Košice, 04011

Other trials in Slovakia

Australia1 site

  • Sydney Adventist Hospital

    Sydney, NSW 2076

Other trials in Australia

Czechia1 site

  • Fakultni Nemocnice u Svety Anny

    Brno, 65691

Other trials in Czechia

Israel1 site

  • Wolfson Medical Center

    Holon, 58100

Other trials in Israel

Spain1 site

  • Hospital Universitario La Fé

    Valencia, E-46009

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
Rate-adaptive pacemaker: accelerometer, Rate-adaptive pacemaker: Closed Loop Stimulation
Keywords
Pacing, Rate-adaptive, Quality of life, Cognitive performance, Atrial fibrillation, Pacemaker sensor
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rate-adaptive pacemaker: accelerometerDevice

    Accelerometer based pacing rate adaptation

  • Rate-adaptive pacemaker: Closed Loop StimulationDevice

    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.

Study groups in NCT00323661
Study groupRoleWhat they receive
1ExperimentalRate-adaptation by Closed Loop Stimulation
Receives: Device: Rate-adaptive pacemaker: Closed Loop Stimulation
2Active comparatorAccelerometer based pacing rate adaptation
Receives: Device: Rate-adaptive pacemaker: accelerometer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive performance assessed by the Number Connection Test

    Measured: 24 months

Secondary outcomes (5)

  1. Quality of life assessed by the SF-08

    Measured: 12 months and 24 months

  2. occurrence of atrial fibrillation

    Measured: 12 months and 24 months

  3. occurrence of serious adverse events

    Measured: 12 months and 24 months

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

    Measured: 12 months and 24 months

  5. Home Monitoring data

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionNov 2010
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
405 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00323661
Sponsor's protocol ID
BA079
Acronym
COGNITION
Status last verified
Feb 2012
First submitted
8 May 2006
Last updated
13 Feb 2012
Results posted
No

Publications

  • Wiegand U, Nuernberg M, Maier SK, Weiss C, Sancho-Tello MJ, Hartmann A, Schuchert A, Maier P, Chan NY. The COGNITION study rationale and design: influence of closed loop stimulation on cognitive performance in pacemaker patients. Pacing Clin Electrophysiol. 2008 Jun;31(6):709-13. doi: 10.1111/j.1540-8159.2008.01075.x.

    PubMed 18507543

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rate-adaptive pacemaker: accelerometer and Rate-adaptive pacemaker: Closed Loop Stimulation in people with Cardiac Pacing, Artificial, run by Biotronik SE & Co. KG at 55 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in Germany, Canada, Austria, Brazil, Hong Kong and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive performance assessed by the Number Connection Test (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00323661, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2012.

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