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

• Conditions: Arrhythmia; Heart Diseases

• Registration Number: NCT00135174
• Lead Sponsor: UMC Utrecht

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).

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-08-23
• Study First Submitted QC: 2005-08-23
• Study First Posted: 2005-08-25
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-12
• Last Update Posted: 2008-06-17
• Primary Completion: 2012-01
• Study Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1526

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Julius Center for Primary Care and Health Sciences, University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands