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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. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by UMC Utrecht.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
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
ClinicalTrials.gov Identifier:
NCT00135174
First received: August 23, 2005
Last updated: June 12, 2008
Last verified: June 2008
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| 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 :
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| Study Type ICMJE | Observational | |||||||||
| Study Design ICMJE | 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 ICMJE |
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| Intervention ICMJE | 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 ICMJE | Unknown status | |||||||||
| 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:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Senior) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Netherlands | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT00135174 | |||||||||
| Other Study ID Numbers ICMJE | 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 ICMJE | UMC Utrecht | |||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | UMC Utrecht | |||||||||
| Verification Date | June 2008 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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