Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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