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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00323661




Registration number
NCT00323661
Ethics application status
Date submitted
8/05/2006
Date registered
9/05/2006
Date last updated
13/02/2012

Titles & IDs
Public title
Closed Loop Stimulation, Cognitive Performance, and Quality of Life in Pacemaker Patients
Scientific title
COGNITION - Cognitive Performance & Closed Loop Stimulation
Secondary ID [1] 0 0
BA079
Universal Trial Number (UTN)
Trial acronym
COGNITION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Pacing, Artificial 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Rate-adaptive pacemaker: accelerometer
Treatment: Devices - Rate-adaptive pacemaker: Closed Loop Stimulation

Experimental: 1 - Rate-adaptation by Closed Loop Stimulation

Active comparator: 2 - Accelerometer based pacing rate adaptation


Treatment: Devices: Rate-adaptive pacemaker: accelerometer
Accelerometer based pacing rate adaptation

Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cognitive performance assessed by the Number Connection Test
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
Quality of life assessed by the SF-08
Timepoint [1] 0 0
12 months and 24 months
Secondary outcome [2] 0 0
occurrence of atrial fibrillation
Timepoint [2] 0 0
12 months and 24 months
Secondary outcome [3] 0 0
occurrence of serious adverse events
Timepoint [3] 0 0
12 months and 24 months
Secondary outcome [4] 0 0
self-assessment of general well-being, mental and physical performance assessed by Visual Analogue Scales
Timepoint [4] 0 0
12 months and 24 months
Secondary outcome [5] 0 0
Home Monitoring data
Timepoint [5] 0 0
24 months

Eligibility
Key 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
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Age under 55
* Pregnant and breast-feeding women
* Patients who are already enrolled in another study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2011
Sample size
Target
Accrual to date
Final
405
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sydney Adventist Hospital - Sydney
Recruitment postcode(s) [1] 0 0
NSW 2076 - Sydney
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Linz
Country [2] 0 0
Austria
State/province [2] 0 0
Ried
Country [3] 0 0
Austria
State/province [3] 0 0
Steyr
Country [4] 0 0
Austria
State/province [4] 0 0
Wien
Country [5] 0 0
Brazil
State/province [5] 0 0
Brasilia - DF
Country [6] 0 0
Brazil
State/province [6] 0 0
Porto Alegre
Country [7] 0 0
Brazil
State/province [7] 0 0
Sao Paulo
Country [8] 0 0
Canada
State/province [8] 0 0
Burnaby, B.C.
Country [9] 0 0
Canada
State/province [9] 0 0
Kelowna BC
Country [10] 0 0
Canada
State/province [10] 0 0
Montreal
Country [11] 0 0
Canada
State/province [11] 0 0
Surrey BC
Country [12] 0 0
Canada
State/province [12] 0 0
Toronto, Ontario
Country [13] 0 0
Czech Republic
State/province [13] 0 0
Brno
Country [14] 0 0
Germany
State/province [14] 0 0
Aachen
Country [15] 0 0
Germany
State/province [15] 0 0
Bielefeld
Country [16] 0 0
Germany
State/province [16] 0 0
Bocholt
Country [17] 0 0
Germany
State/province [17] 0 0
Coburg
Country [18] 0 0
Germany
State/province [18] 0 0
Detmold
Country [19] 0 0
Germany
State/province [19] 0 0
Dresden
Country [20] 0 0
Germany
State/province [20] 0 0
Ebersberg
Country [21] 0 0
Germany
State/province [21] 0 0
Erftstadt-Frauenthal
Country [22] 0 0
Germany
State/province [22] 0 0
Erlabrunn
Country [23] 0 0
Germany
State/province [23] 0 0
Essen
Country [24] 0 0
Germany
State/province [24] 0 0
Frankfurt
Country [25] 0 0
Germany
State/province [25] 0 0
Gütersloh
Country [26] 0 0
Germany
State/province [26] 0 0
Halle
Country [27] 0 0
Germany
State/province [27] 0 0
Hamburg
Country [28] 0 0
Germany
State/province [28] 0 0
Hanau
Country [29] 0 0
Germany
State/province [29] 0 0
Hannover
Country [30] 0 0
Germany
State/province [30] 0 0
Heidelberg
Country [31] 0 0
Germany
State/province [31] 0 0
Herford
Country [32] 0 0
Germany
State/province [32] 0 0
Holzminden
Country [33] 0 0
Germany
State/province [33] 0 0
Jena
Country [34] 0 0
Germany
State/province [34] 0 0
Kiel
Country [35] 0 0
Germany
State/province [35] 0 0
Leipzig
Country [36] 0 0
Germany
State/province [36] 0 0
Lübeck
Country [37] 0 0
Germany
State/province [37] 0 0
Mönchengladbach
Country [38] 0 0
Germany
State/province [38] 0 0
Paderborn
Country [39] 0 0
Germany
State/province [39] 0 0
Papenburg
Country [40] 0 0
Germany
State/province [40] 0 0
Quakenbrück
Country [41] 0 0
Germany
State/province [41] 0 0
Recklinghausen
Country [42] 0 0
Germany
State/province [42] 0 0
Reinbek
Country [43] 0 0
Germany
State/province [43] 0 0
Riesa
Country [44] 0 0
Germany
State/province [44] 0 0
Trier
Country [45] 0 0
Germany
State/province [45] 0 0
Viersen
Country [46] 0 0
Germany
State/province [46] 0 0
Würzburg
Country [47] 0 0
Hong Kong
State/province [47] 0 0
Hong Kong
Country [48] 0 0
Israel
State/province [48] 0 0
Holon
Country [49] 0 0
Slovakia
State/province [49] 0 0
Bratislava
Country [50] 0 0
Slovakia
State/province [50] 0 0
Kosice
Country [51] 0 0
Spain
State/province [51] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biotronik SE & Co. KG
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00323661
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Uwe Wiegand, Prof. Dr.
Address 0 0
Sana-Klinikum Remscheid, 42859 Remscheid, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00323661