Clinical trial NCT00135174: Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The Followpace Study
Official title: Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The FOLLOWPACE Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arrhythmia
Heart Diseases
Keywords: Pacemaker
routine
follow-up
complications
Quality of Life
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: College of Health Insurers/Society of Academic Hospitals,
name: Dutch Working Group on Cardiac Pacing,
name: Foundation Pacemaker Registry in The Netherlands,
First posted: 2005-08-25
Enrollment: 1526
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring a PM for conventional reasons.

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 time.

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 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).

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Julius Center for Primary Care and Health Sciences, University Medical Center Utrecht
Study officials:
affiliation: University of Utrecht, Julius Center for Primary Care and Health Sciences
name: Norbert van Hemel, M.D.
role: STUDY_CHAIR
affiliation: University of Utrecht, Julius Center for Primary Care and Health Sciences
name: Karel G Moons, PhD
role: STUDY_CHAIR
affiliation: University of Utrecht, Julius Center for Primary Care and Health Sciences
name: Diederick E Grobbee, M.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.