Status:
COMPLETED
Setrox JS Master Study
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Cardiac Disease
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is the evaluation of safety and efficacy of the pacemaker lead "Setrox JS".
Eligibility Criteria
Inclusion
- Meet the indications for pacemaker therapy
- Available for follow-up visits on a regular basis at the investigational site
- Contractual capability and ability to consent
- Age ≥18 years
Exclusion
- Meet one or more of the contraindications for pacemaker therapy
- Permanent atrial fibrillation
- 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
- Pregnant and breast-feeding women
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01487941
Start Date
December 1 2011
End Date
October 1 2014
Last Update
November 20 2014
Active Locations (1)
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1
SV. Anny Clinic Brno
Brno, Czechia, 656 91