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

Heart Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00135174
• Other study ID #: CVZ/VAZ 01236
• Status: Active, not recruiting
• Phase: N/A
• First received: August 23, 2005
• Last updated: June 12, 2008
• Start date: September 2003
• Est. completion date: January 2012

Study information

• Verified date: June 2008
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1526
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arrhythmia
• Heart Diseases

Locations

Country	Name	City	State
Netherlands	Julius Center for Primary Care and Health Sciences, University Medical Center Utrecht	Utrecht

Sponsors (4)

Lead Sponsor	Collaborator
UMC Utrecht	College of Health Insurers/Society of Academic Hospitals,, Dutch Working Group on Cardiac Pacing,, Foundation Pacemaker Registry in The Netherlands,

Country where clinical trial is conducted

Netherlands, 

External Links

•   Electronic CRF pages and entire protocol can be viewed here.
•   Webpage with information on study center.