Complications Following Pacemaker Implantation
This study has been completed.
Sponsor:
University of Aarhus
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01038180
First received: December 21, 2009
Last updated: December 22, 2009
Last verified: December 2009
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 21, 2009 | ||||
| Last Updated Date | December 22, 2009 | ||||
| Start Date ICMJE | January 1997 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01038180 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 | Complications Following Pacemaker Implantation | ||||
| Official Title ICMJE | Complications Following Pacemaker or ICD Implantation: Results From The Danish Pacemaker and ICD Register | ||||
| Brief Summary | This study examines possible risk factors with regard to complications following pacemaker implantation. |
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| Detailed Description | This study examines possible risk factors with regard to complications following pacemaker implantation. We are using data from The Danish Pacemaker Register. |
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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 | Probability Sample | ||||
| Study Population | All Danish patients receiving a permanent cardiac pacemaker during the years 1997 to 2008 |
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| Condition ICMJE | Bradycardia | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | pacemaker group | ||||
| Publications * | Kirkfeldt RE, Johansen JB, Nohr EA, Moller M, Arnsbo P, Nielsen JC. Risk factors for lead complications in cardiac pacing: a population-based cohort study of 28,860 Danish patients. Heart Rhythm. 2011 Oct;8(10):1622-8. Epub 2011 Apr 14. | ||||
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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 | Completed | ||||
| Enrollment ICMJE | 28000 | ||||
| Completion Date | December 2008 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:none |
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01038180 | ||||
| Other Study ID Numbers ICMJE | SKS-REK-1 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Rikke Esberg Kirkfeldt, Aarhus Universityhospital, Skejby | ||||
| Study Sponsor ICMJE | University of Aarhus | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Aarhus | ||||
| Verification Date | December 2009 | ||||
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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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