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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00135174
Other study ID # CVZ/VAZ 01236
Secondary ID
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


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, 

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