Status:
COMPLETED
Master Study for the Investigation of Safety and Efficacy of the EVIA Pacemaker
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Pacemaker Indication
Eligibility:
All Genders
Phase:
NA
Brief Summary
The objective of this study is to prove the safety and efficacy of the EVIA pacemaker. Primarily, the newly implemented Atrial Capture Control algorithm is evaluated, which automatically measures the ...
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
- Patients with chronic atrial fibrillation (dual chamber pacemaker only)
- 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 :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT00916344
Start Date
June 1 2009
End Date
March 1 2010
Last Update
October 7 2011
Active Locations (1)
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1
CHU Bordeaux Haut-Lévêque
Pessac, Bordeaux, France, F - 33604