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

Tracking Information

First Received Date ^ICMJE

August 23, 2005

Last Updated Date

June 12, 2008

Start Date ^ICMJE

September 2003

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00135174 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

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 ^ICMJE

Arrhythmia
Heart Diseases

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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 ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

1526

Estimated Completion Date

January 2012

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00135174

Other Study ID Numbers ^ICMJE

CVZ/VAZ 01236

Has Data Monitoring Committee

Yes

Responsible Party

K.G.M. Moons, Julius Center for Health Sciences and Primary Care

Study Sponsor ^ICMJE

UMC Utrecht

Collaborators ^ICMJE

College of Health Insurers/Society of Academic Hospitals,
Dutch Working Group on Cardiac Pacing,
Foundation Pacemaker Registry in The Netherlands,

Investigators ^ICMJE

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

Information Provided By

UMC Utrecht

Verification Date

June 2008

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

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