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

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ClinicalTrials.gov Identifier: NCT00135174
Recruitment Status : Unknown
Verified June 2008 by UMC Utrecht.
Recruitment status was:  Active, not recruiting
First Posted : August 25, 2005
Last Update Posted : June 17, 2008
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

Tracking Information
First Submitted Date August 23, 2005
First Posted Date August 25, 2005
Last Update Posted Date June 17, 2008
Study Start Date September 2003
Estimated Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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).
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients requiring a PM for conventional reasons.
Condition
  • Arrhythmia
  • Heart Diseases
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: June 12, 2008)
1526
Original Enrollment
 (submitted: August 23, 2005)
2000
Estimated Study Completion Date January 2012
Estimated Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT00135174
Other Study ID Numbers CVZ/VAZ 01236
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party K.G.M. Moons, Julius Center for Health Sciences and Primary Care
Study Sponsor UMC Utrecht
Collaborators
  • College of Health Insurers/Society of Academic Hospitals,
  • Dutch Working Group on Cardiac Pacing,
  • Foundation Pacemaker Registry in The Netherlands,
Investigators
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
PRS Account UMC Utrecht
Verification Date June 2008