Closed Loop Stimulation, Cognitive Performance, and Quality of Life in Pacemaker Patients
NCT ID: NCT00323661
Last Updated: 2012-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
405 participants
INTERVENTIONAL
2006-05-31
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Rate-adaptation by Closed Loop Stimulation
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.
2
Accelerometer based pacing rate adaptation
Rate-adaptive pacemaker: accelerometer
Accelerometer based pacing rate adaptation
Interventions
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Rate-adaptive pacemaker: accelerometer
Accelerometer based pacing rate adaptation
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnant and breast-feeding women
* Patients who are already enrolled in another study
55 Years
ALL
No
Sponsors
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Biotronik SE & Co. KG
INDUSTRY
Responsible Party
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Principal Investigators
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Uwe Wiegand, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Sana-Klinikum Remscheid, 42859 Remscheid, Germany
Locations
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Sydney Adventist Hospital
Sydney, , Australia
A.ö. Krankenhaus der Stadt Linz
Linz, , Austria
Krankenhaus der Barmherzigen Schwestern Ried
Ried, , Austria
A. ö. Landeskrankenhaus Steyr
Steyr, , Austria
Wilhelminenspital der Stadt Wien
Vienna, , Austria
Hospital Anchieta, Instituto do Coracao de Taguatinga
Brasilia - DF, , Brazil
Hospital Sao Francisco
Porto Alegre, , Brazil
Hospital Real e Benemerita Sociedade Portuguesa de Beneficencia
São Paulo, , Brazil
Practice Dr. Bloomberg
Burnaby, B.C., , Canada
Kelowna Cardiology Research
Kelowna BC, , Canada
Hopital Sacre-Coeur
Montreal, , Canada
Dr. Dante Manyauri
Surrey BC, , Canada
Scarborough Cardiology Research
Toronto, Ontario, , Canada
Fakultni Nemocnice u Svety Anny
Brno, , Czechia
Universitätsklinik der RWTH Aachen
Aachen, , Germany
Städtische Kliniken Bielefeld, Klinikum Mitte
Bielefeld, , Germany
St. Agnes Hospital GmbH, 1. Medizinische Klinik-Kardiologie
Bocholt, , Germany
Klinikum Coburg
Coburg, , Germany
Klinikum Lippe-Detmold
Detmold, , Germany
Med. Klinik/Kardiologie, Herzzentrum, Universitätsklinik an der Technischen Universität Dresden
Dresden, , Germany
Kreisklinik Ebersberg GmbH
Ebersberg, , Germany
Marien-Hospital Erftstadt-Frauenthal
Erftstadt-Frauenthal, , Germany
Klinken Erlabrunn GmbH
Erlabrunn, , Germany
Westdeutsches Herzzentrum Essen; Klinik für Kardiologie und Thorax-Kardiovaskuläre Chirurgie des Universitätsklinikums Essen
Essen, , Germany
Kardiologisches Zentrum am Zoo
Frankfurt, , Germany
St. Elisabeth-Hospital
Gütersloh, , Germany
Klinikum der Medizinischen Fakultät Halle-Wittenberg
Halle, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Zentrum für Kardiologische und Angiologische Medizin Hamburg
Hamburg, , Germany
AK Altona
Hamburg, , Germany
St. Vinzenz-Krankenhaus Hanau gGmbH
Hanau, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Klinikum Herford
Herford, , Germany
Evangelisches Krankenhaus Holzminden
Holzminden, , Germany
Klinikum der Universität Jena Klinik für Innere Medizin I
Jena, , Germany
Kardiologische Gemeinschaftspraxis
Kiel, , Germany
Städtisches Klinikum St. Georg
Leipzig, , Germany
Universitätsklinikum Lübeck
Lübeck, , Germany
Krankenhaus St. Franziskus, Medizinische Klinik II
Mönchengladbach, , Germany
St. Vincenz-Krankenhaus GmbH
Paderborn, , Germany
Kardiologische Praxis
Papenburg, , Germany
Christl. Krankenhaus Quakenbrück
Quakenbrück, , Germany
Elisabeth Krankenhaus GmbH
Recklinghausen, , Germany
St. Adolf-Stift
Reinbek, , Germany
Gemeinschaftspraxis Dr. Stenzel/Dr. Ebert
Riesa, , Germany
Evangelisches Elisabeth Krankenhaus
Trier, , Germany
Gemeinschaftspraxis Drs. Schley, Burkhard-Meier, Schemeitat
Viersen, , Germany
Universitätsklinikum Würzburg
Würzburg, , Germany
Princess Margaret Hospital
Hong Kong, , Hong Kong
Yan Chai Hospital
Hong Kong, , Hong Kong
Wolfson Medical Center
Holon, , Israel
Nemocnica Ministerstva Obrany
Bratislava, , Slovakia
VUSCH East Slovak Cardiology Institute, Arytmology
Košice, , Slovakia
Hospital Universitario La Fé
Valencia, , Spain
Countries
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References
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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.
Other Identifiers
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BA079
Identifier Type: -
Identifier Source: org_study_id
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