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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.


Clinical Trial 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). ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT00135174
Study type Observational
Source UMC Utrecht
Contact
Status Active, not recruiting
Phase N/A
Start date September 2003
Completion date January 2012

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