Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The Followpace Study
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| ClinicalTrials.gov Identifier: NCT00135174 |
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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 | |||||||||