SIELLO Pilot Study for Comparison of Steroid Versus Non-Steroid Pacing Leads
NCT ID: NCT01000532
Last Updated: 2011-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
88 participants
OBSERVATIONAL
2009-10-31
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pacemaker therapy
SIELLO JT/T
Implantation of SIELLO and BPPU pacemaker leads
Pacemaker therapy
Pacemaker therapy
BPPU JT/T
Implantation of SIELLO and BPPU pacemaker leads
Interventions
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SIELLO JT/T
Implantation of SIELLO and BPPU pacemaker leads
Pacemaker therapy
Pacemaker therapy
BPPU JT/T
Implantation of SIELLO and BPPU pacemaker leads
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Understand the nature of the procedure
* Give informed consent
* Able to complete all testing required by the clinical protocol
* Available for follow-up visits on a regular basis at the investigational site
Exclusion Criteria
* Meet one or more of the contraindications
* Have a life expectancy of less than six months
* Cardiac surgery in the next six months
* Enrolled in another cardiac clinical investigation
* Have other medical devices that may interact with the implanted pacemaker
18 Years
ALL
No
Sponsors
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Biotronik SE & Co. KG
INDUSTRY
Responsible Party
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Principal Investigators
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Béla Merkely, Professor
Role: PRINCIPAL_INVESTIGATOR
Semmelweis University Heart Center, Budapest, Hungary
Locations
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Semmelweis University
Budapest, , Hungary
Countries
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References
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Kutyifa V, Zima E, Molnar L, Kuehne C, Theiss S, Herrmann G, Geller L, Merkely B. Direct comparison of steroid and non-steroid eluting small surface pacing leads: randomized, multicenter clinical trial. Cardiol J. 2013;20(4):431-8. doi: 10.5603/CJ.2013.0103.
Other Identifiers
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47-1
Identifier Type: -
Identifier Source: org_study_id