Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The Followpace Study
NCT ID: NCT00135174
Last Updated: 2008-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1526 participants
OBSERVATIONAL
2003-09-30
2012-01-31
Brief Summary
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Detailed Description
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* 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).
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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College of Health Insurers/Society of Academic Hospitals,
UNKNOWN
Dutch Working Group on Cardiac Pacing,
UNKNOWN
Foundation Pacemaker Registry in The Netherlands,
UNKNOWN
UMC Utrecht
OTHER
Responsible Party
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Julius Center for Health Sciences and Primary Care
Principal Investigators
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Norbert van Hemel, M.D.
Role: STUDY_CHAIR
University of Utrecht, Julius Center for Primary Care and Health Sciences
Karel G Moons, PhD
Role: STUDY_CHAIR
University of Utrecht, Julius Center for Primary Care and Health Sciences
Diederick E Grobbee, M.D.
Role: STUDY_CHAIR
University of Utrecht, Julius Center for Primary Care and Health Sciences
Locations
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Julius Center for Primary Care and Health Sciences, University Medical Center Utrecht
Utrecht, Utrecht, Netherlands
Countries
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References
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Udo EO, van Hemel NM, Zuithoff NP, Doevendans PA, Moons KG. Risk of heart failure- and cardiac death gradually increases with more right ventricular pacing. Int J Cardiol. 2015 Apr 15;185:95-100. doi: 10.1016/j.ijcard.2015.03.053. Epub 2015 Mar 5.
Udo EO, van Hemel NM, Zuithoff NP, Doevendans PA, Moons KG. Prognosis of the bradycardia pacemaker recipient assessed at first implantation: a nationwide cohort study. Heart. 2013 Nov;99(21):1573-8. doi: 10.1136/heartjnl-2013-304445. Epub 2013 Aug 22.
Udo EO, van Hemel NM, Zuithoff NP, Nijboer H, Taks W, Doevendans PA, Moons KG. Long term quality-of-life in patients with bradycardia pacemaker implantation. Int J Cardiol. 2013 Oct 3;168(3):2159-63. doi: 10.1016/j.ijcard.2013.01.253. Epub 2013 Feb 28.
Udo EO, van Hemel NM, Zuithoff NP, Dijk WA, Hooijschuur CA, Doevendans PA, Moons KG. Pacemaker follow-up: are the latest guidelines in line with modern pacemaker practice? Europace. 2013 Feb;15(2):243-51. doi: 10.1093/europace/eus310. Epub 2012 Oct 24.
Udo EO, van Hemel NM, Zuithoff NP, Kelder JC, Crommentuijn HA, Koopman-Verhagen AM, Voskuil T, Doevendans PA, Moons KG. Long-term outcome of cardiac pacing in octogenarians and nonagenarians. Europace. 2012 Apr;14(4):502-8. doi: 10.1093/europace/eur329. Epub 2011 Oct 23.
Related Links
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Webpage with information on study center.
Electronic CRF pages and entire protocol can be viewed here.
Other Identifiers
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CVZ/VAZ 01236
Identifier Type: -
Identifier Source: org_study_id