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

1526

Original Enrollment

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

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

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