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Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The Followpace Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by UMC Utrecht.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
College of Health Insurers/Society of Academic Hospitals,
Dutch Working Group on Cardiac Pacing,
Foundation Pacemaker Registry in The Netherlands,
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00135174
First received: August 23, 2005
Last updated: June 12, 2008
Last verified: June 2008

August 23, 2005
June 12, 2008
September 2003
January 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00135174 on ClinicalTrials.gov Archive Site
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Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The Followpace Study
Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The FOLLOWPACE Study

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.

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).
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients requiring a PM for conventional reasons.

  • Arrhythmia
  • Heart Diseases
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1526
January 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00135174
CVZ/VAZ 01236
Yes
K.G.M. Moons, Julius Center for Health Sciences and Primary Care
UMC Utrecht
  • College of Health Insurers/Society of Academic Hospitals,
  • Dutch Working Group on Cardiac Pacing,
  • Foundation Pacemaker Registry in The Netherlands,
Study Chair: Norbert van Hemel, M.D. University of Utrecht, Julius Center for Primary Care and Health Sciences
Study Chair: Karel G Moons, PhD University of Utrecht, Julius Center for Primary Care and Health Sciences
Study Chair: Diederick E Grobbee, M.D. University of Utrecht, Julius Center for Primary Care and Health Sciences
UMC Utrecht
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP