Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The Followpace Study
Recruitment status was Active, not recruiting
The overall objective of the study is to quantify the true prognostic value and cost-effectiveness of routine follow-up visits in patients who receive an approved pacemaker of any type for the first time.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The FOLLOWPACE Study|
|Study Start Date:||September 2003|
|Estimated Study Completion Date:||January 2012|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Specific objectives :
- To determine the incidence of complications occurring in the first year after implantation of a pacemaker.
- To determine the quality of life at one year after pacemaker implantation in comparison with the quality of life before implantation.
- To determine which baseline (patient and pacemaker related) characteristics measured during implantation are prognostic predictors for the occurrence of complications and quality of life after one year.
- To determine which characteristics measured during follow-up visits truly have added predictive value, and to what extent.
- To determine to what extent responsibilities for pacemaker check-up can be safely delegated to non-cardiologists (e.g. pacemaker technicians or manufacturers' delegates).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00135174
|Julius Center for Primary Care and Health Sciences, University Medical Center Utrecht|
|Utrecht, Netherlands, 3508 GA|
|Study Chair:||Norbert van Hemel, M.D.||University of Utrecht, Julius Center for Primary Care and Health Sciences|
|Study Chair:||Karel G Moons, PhD||University of Utrecht, Julius Center for Primary Care and Health Sciences|
|Study Chair:||Diederick E Grobbee, M.D.||University of Utrecht, Julius Center for Primary Care and Health Sciences|