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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00135174

Enrollment

1526

Registered

2005-08-25

Start date

2003-09-30

Completion date

2012-01-31

Last updated

2008-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia, Heart Diseases

Keywords

Pacemaker, routine, follow-up, complications, Quality of Life

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Countries

Netherlands

Outcome results