Status:
UNKNOWN
Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The Followpace Study
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
College of Health Insurers/Society of Academic Hospitals,
Dutch Working Group on Cardiac Pacing,
Conditions:
Arrhythmia
Heart Diseases
Eligibility:
All Genders
18+ years
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 t...
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 impla...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
1526 Patients enrolled
Trial Details
Trial ID
NCT00135174
Start Date
September 1 2003
End Date
January 1 2012
Last Update
June 17 2008
Active Locations (1)
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1
Julius Center for Primary Care and Health Sciences, University Medical Center Utrecht
Utrecht, Utrecht, Netherlands, 3508 GA