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.
Full Title of Study: “Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The FOLLOWPACE Study”
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: January 2012
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).
Participating in This Clinical Trial
- Each patient aged 18 years or over receiving a pacemaker for the first time in one of the participating Dutch pacemaker implanting centers, is a potential candidate for the study. Exclusion Criteria:
- Patients are not eligible if they refuse to sign informed consent on use of personal medical data. – Patients who are taking any investigational (new) drug or have a non-approved or investigational pacemaker system which requires unusual follow-up regarding the pacemaker – Patients having diseases that are likely to cause death or significant morbidity during the study period such as neoplasia and immune, infectious or degenerative diseases will be excluded.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- UMC Utrecht
- College of Health Insurers/Society of Academic Hospitals,
- Provider of Information About this Clinical Study
- K.G.M. Moons, Julius Center for Health Sciences and Primary Care
- Overall Official(s)
- Norbert van Hemel, M.D., Study Chair, University of Utrecht, Julius Center for Primary Care and Health Sciences
- Karel G Moons, PhD, Study Chair, University of Utrecht, Julius Center for Primary Care and Health Sciences
- Diederick E Grobbee, M.D., Study Chair, University of Utrecht, Julius Center for Primary Care and Health Sciences
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