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
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Sponsor:
UMC Utrecht
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 | ||||||||||
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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 | Complete list of historical versions of study NCT00135174 on ClinicalTrials.gov Archive Site | |||||||||
Current Secondary Outcome Measures | Not Provided | |||||||||
Original Secondary Outcome Measures | Not Provided | |||||||||
Current Other Outcome Measures | Not Provided | |||||||||
Original Other 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 :
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Study Type | Observational | |||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||||||||
Biospecimen | Not Provided | |||||||||
Sampling Method | Non-Probability Sample | |||||||||
Study Population | Patients requiring a PM for conventional reasons. | |||||||||
Condition |
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Intervention | Not Provided | |||||||||
Study Groups/Cohorts | Not Provided | |||||||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||||||||
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 |
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Investigators |
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PRS Account | UMC Utrecht | |||||||||
Verification Date | June 2008 |