Status:
COMPLETED
Closed Loop Stimulation, Cognitive Performance, and Quality of Life in Pacemaker Patients
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Cardiac Pacing, Artificial
Eligibility:
All Genders
55+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- Age under 55
- Pregnant and breast-feeding women
- Patients who are already enrolled in another study
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
405 Patients enrolled
Trial Details
Trial ID
NCT00323661
Start Date
May 1 2006
End Date
March 1 2011
Last Update
February 13 2012
Active Locations (55)
Enter a location and click search to find clinical trials sorted by distance.
1
Sydney Adventist Hospital
Sydney, Australia, NSW 2076
2
A.ö. Krankenhaus der Stadt Linz
Linz, Austria, 4020
3
Krankenhaus der Barmherzigen Schwestern Ried
Ried, Austria, 4910
4
A. ö. Landeskrankenhaus Steyr
Steyr, Austria, 4400