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

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2012

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).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • UMC Utrecht
  • Collaborator
    • College of Health Insurers/Society of Academic Hospitals,
  • Provider of Information About this Clinical Study
    • K.G.M. Moons, Julius Center for Health Sciences and Primary Care
  • Overall Official(s)
    • Norbert van Hemel, M.D., Study Chair, University of Utrecht, Julius Center for Primary Care and Health Sciences
    • Karel G Moons, PhD, Study Chair, University of Utrecht, Julius Center for Primary Care and Health Sciences
    • Diederick E Grobbee, M.D., Study Chair, University of Utrecht, Julius Center for Primary Care and Health Sciences

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.