Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The Followpace Study
This trial is active, not recruiting.
|Conditions||arrhythmia, heart diseases|
|Collaborator||College of Health Insurers/Society of Academic Hospitals,|
|Start date||September 2003|
|End date||January 2012|
|Trial size||1526 participants|
|Trial identifier||NCT00135174, CVZ/VAZ 01236|
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.
Male or female participants at least 18 years old.
Inclusion Criteria: - 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.
|Official title||Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The FOLLOWPACE Study|
|Description||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).|
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