Status:
COMPLETED
Master Study for the Investigation of Safety and Efficacy of the SIELLO Pacemaker Leads
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Cardiac Pacemaker Syndrome
Eligibility:
All Genders
Phase:
NA
Brief Summary
The objective of this study is to prove the safety and efficacy of the SIELLO pacemaker leads.
Detailed Description
The assessment of the safety of SIELLO pacemaker leads is based on the collection of complications which are related to the leads. The assessment of efficacy of the SIELLO pacemaker leads is based on ...
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 :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT00943046
Start Date
July 1 2009
End Date
December 1 2010
Last Update
July 26 2019
Active Locations (1)
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1
Allgemeines Krankenhaus Hamburg Altona
Hamburg, Germany, 22763