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

Cardiac Pacing, Artificial Clinical Trial

— COGNITION  

Official title:

COGNITION - Cognitive Performance & Closed Loop Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00323661
• Other study ID #: BA079
• Status: Completed
• Phase: Phase 4
• First received: May 8, 2006
• Last updated: February 10, 2012
• Start date: May 2006
• Est. completion date: March 2011

Study information

• Verified date: February 2012
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: March 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Pacing, Artificial

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Australia	Sydney Adventist Hospital	Sydney
Austria	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	Wien
Brazil	Hospital Anchieta, Instituto do Coracao de Taguatinga	Brasilia - DF
Brazil	Hospital Sao Francisco	Porto Alegre
Brazil	Hospital Real e Benemerita Sociedade Portuguesa de Beneficencia	Sao Paulo
Canada	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
Czech Republic	Fakultni Nemocnice u Svety Anny	Brno
Germany	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	AK Altona	Hamburg
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Zentrum für Kardiologische und Angiologische Medizin Hamburg	Hamburg
Germany	St. Vinzenz-Krankenhaus Hanau gGmbH	Hanau
Germany	Medizinische Hochschule Hannover	Hannover
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
Hong Kong	Princess Margaret Hospital	Hong Kong
Hong Kong	Yan Chai Hospital	Hong Kong
Israel	Wolfson Medical Center	Holon
Slovakia	Nemocnica Ministerstva Obrany	Bratislava
Slovakia	VUSCH East Slovak Cardiology Institute, Arytmology	Kosice
Spain	Hospital Universitario La Fé	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Australia,  Austria,  Brazil,  Canada,  Czech Republic,  Germany,  Hong Kong,  Israel,  Slovakia,  Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive performance assessed by the Number Connection Test		24 months	No
Secondary	Quality of life assessed by the SF-08		12 months and 24 months	No
Secondary	occurrence of atrial fibrillation		12 months and 24 months	No
Secondary	occurrence of serious adverse events		12 months and 24 months	No
Secondary	self-assessment of general well-being, mental and physical performance assessed by Visual Analogue Scales		12 months and 24 months	No
Secondary	Home Monitoring data		24 months	No