Clinical trial NCT00323661: Closed Loop Stimulation, Cognitive Performance, and Quality of Life in Pacemaker Patients
Official title: COGNITION - Cognitive Performance & Closed Loop Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiac Pacing, Artificial
Keywords: Pacing
Rate-adaptive
Quality of life
Cognitive performance
Atrial fibrillation
Pacemaker sensor
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2006-05-09
Enrollment: 405
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Cognitive performance assessed by the Number Connection Test
timeFrame: 24 months
Secondary outcomes:
measure: Quality of life assessed by the SF-08
timeFrame: 12 months and 24 months
measure: occurrence of atrial fibrillation
timeFrame: 12 months and 24 months
measure: occurrence of serious adverse events
timeFrame: 12 months and 24 months
measure: self-assessment of general well-being, mental and physical performance assessed by Visual Analogue Scales
timeFrame: 12 months and 24 months
measure: Home Monitoring data
timeFrame: 24 months
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Sydney Adventist Hospital
city: Linz
country: Austria
facility: A.ö. Krankenhaus der Stadt Linz
city: Ried
country: Austria
facility: Krankenhaus der Barmherzigen Schwestern Ried
city: Steyr
country: Austria
facility: A. ö. Landeskrankenhaus Steyr
city: Wien
country: Austria
facility: Wilhelminenspital der Stadt Wien
city: Brasilia - DF
country: Brazil
facility: Hospital Anchieta, Instituto do Coracao de Taguatinga
city: Porto Alegre
country: Brazil
facility: Hospital Sao Francisco
city: Sao Paulo
country: Brazil
facility: Hospital Real e Benemerita Sociedade Portuguesa de Beneficencia
city: Burnaby, B.C.
country: Canada
facility: Practice Dr. Bloomberg
city: Kelowna BC
country: Canada
facility: Kelowna Cardiology Research
city: Montreal
country: Canada
facility: Hopital Sacre-Coeur
city: Surrey BC
country: Canada
facility: Dr. Dante Manyauri
city: Toronto, Ontario
country: Canada
facility: Scarborough Cardiology Research
city: Brno
country: Czech Republic
facility: Fakultni Nemocnice u Svety Anny
city: Aachen
country: Germany
facility: Universitätsklinik der RWTH Aachen
city: Bielefeld
country: Germany
facility: Städtische Kliniken Bielefeld, Klinikum Mitte
city: Bocholt
country: Germany
facility: St. Agnes Hospital GmbH, 1. Medizinische Klinik-Kardiologie
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Detmold
country: Germany
facility: Klinikum Lippe-Detmold
city: Dresden
country: Germany
facility: Med. Klinik/Kardiologie, Herzzentrum, Universitätsklinik an der Technischen Universität Dresden
city: Ebersberg
country: Germany
facility: Kreisklinik Ebersberg GmbH
city: Erftstadt-Frauenthal
country: Germany
facility: Marien-Hospital Erftstadt-Frauenthal
city: Erlabrunn
country: Germany
facility: Klinken Erlabrunn GmbH
city: Essen
country: Germany
facility: Westdeutsches Herzzentrum Essen; Klinik für Kardiologie und Thorax-Kardiovaskuläre Chirurgie des Universitätsklinikums Essen
city: Frankfurt
country: Germany
facility: Kardiologisches Zentrum am Zoo
city: Gütersloh
country: Germany
facility: St. Elisabeth-Hospital
city: Halle
country: Germany
facility: Klinikum der Medizinischen Fakultät Halle-Wittenberg
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Zentrum für Kardiologische und Angiologische Medizin Hamburg
city: Hamburg
country: Germany
facility: AK Altona
city: Hanau
country: Germany
facility: St. Vinzenz-Krankenhaus Hanau gGmbH
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Herford
country: Germany
facility: Klinikum Herford
city: Holzminden
country: Germany
facility: Evangelisches Krankenhaus Holzminden
city: Jena
country: Germany
facility: Klinikum der Universität Jena Klinik für Innere Medizin I
city: Kiel
country: Germany
facility: Kardiologische Gemeinschaftspraxis
city: Leipzig
country: Germany
facility: Städtisches Klinikum St. Georg
city: Lübeck
country: Germany
facility: Universitätsklinikum Lübeck
city: Mönchengladbach
country: Germany
facility: Krankenhaus St. Franziskus, Medizinische Klinik II
city: Paderborn
country: Germany
facility: St. Vincenz-Krankenhaus GmbH
city: Papenburg
country: Germany
facility: Kardiologische Praxis
city: Quakenbrück
country: Germany
facility: Christl. Krankenhaus Quakenbrück
city: Recklinghausen
country: Germany
facility: Elisabeth Krankenhaus GmbH
city: Reinbek
country: Germany
facility: St. Adolf-Stift
city: Riesa
country: Germany
facility: Gemeinschaftspraxis Dr. Stenzel/Dr. Ebert
city: Trier
country: Germany
facility: Evangelisches Elisabeth Krankenhaus
city: Viersen
country: Germany
facility: Gemeinschaftspraxis Drs. Schley, Burkhard-Meier, Schemeitat
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital
city: Hong Kong
country: Hong Kong
facility: Yan Chai Hospital
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Bratislava
country: Slovakia
facility: Nemocnica Ministerstva Obrany
city: Kosice
country: Slovakia
facility: VUSCH East Slovak Cardiology Institute, Arytmology
city: Valencia
country: Spain
facility: Hospital Universitario La Fé
Study officials:
affiliation: Sana-Klinikum Remscheid, 42859 Remscheid, Germany
name: Uwe Wiegand, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.