Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The FOLLOWPACE Study

UMC Utrecht1 site in 1 country1,526 target enrollmentSeptember 2003

ConditionsArrhythmia Heart Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Arrhythmia
Sponsor: UMC Utrecht
Enrollment: 1526
Locations: 1
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed 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).

Registry

clinicaltrials.gov

Start Date

September 2003

End Date

January 2012

Last Updated

17 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

UMC Utrecht

Eligibility Criteria

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.