Status:
COMPLETED
SIELLO Pilot Study for Comparison of Steroid Versus Non-Steroid Pacing Leads
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Arrhythmias, Cardiac
Eligibility:
All Genders
18+ years
Brief Summary
This investigation is designed to demonstrate the clinical efficacy and safety of the low-dose drug of the SIELLO leads in comparison to the non-steroid BPPU leads in a clinical investigation.
Eligibility Criteria
Inclusion
- Meet the indications for pacemaker therapy
- 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
- Meet none of the pacemaker indications
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT01000532
Start Date
October 1 2009
End Date
February 1 2011
Last Update
November 16 2011
Active Locations (1)
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1
Semmelweis University
Budapest, Hungary