Overview

This trial is active, not recruiting.

Conditions arrhythmia, heart diseases
Sponsor UMC Utrecht
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

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Eligibility Criteria

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.

Additional Information

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).
Trial information was received from ClinicalTrials.gov and was last updated in June 2008.
Information provided to ClinicalTrials.gov by UMC Utrecht.