NCT00135174

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,526 (actual)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Arrhythmia
• Heart Diseases

Timeline

• Start date: 2003-09-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2005-08-25
• Last updated: 2008-06-17

Locations

1 site across 1 country: Netherlands