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

UMC Utrecht

Status: Unknown

Conditions: Arrhythmia; Heart Diseases

Study type: Observational

Funder types: Other

Identifiers

NCT00135174

CVZ/VAZ 01236

Details and patient eligibility

About

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 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).

Enrollment: 1,526 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.