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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
History of Changes
  Purpose

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.


Condition
Arrhythmia
Heart Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The FOLLOWPACE Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UMC Utrecht:

Enrollment: 1526
Study Start Date: September 2003
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients requiring a PM for conventional reasons.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00135174

Locations
Netherlands
Julius Center for Primary Care and Health Sciences, University Medical Center Utrecht
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
UMC Utrecht
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
  More Information

Additional Information:
Webpage with information on study center.  This link exits the ClinicalTrials.gov site

No publications provided by UMC Utrecht

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: K.G.M. Moons, Julius Center for Health Sciences and Primary Care
ClinicalTrials.gov Identifier: NCT00135174     History of Changes
Other Study ID Numbers: CVZ/VAZ 01236
Study First Received: August 23, 2005
Last Updated: June 12, 2008
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
Pacemaker
routine
follow-up
complications
Quality of Life

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013