Status:
COMPLETED
Lumax DX / Linox DX Evaluation
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Cardiac Disease
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this study is to investigate the safety and efficacy of the Lumax DX / Linox DX system. No hypothesis has been defined.
Eligibility Criteria
Inclusion
- Patient meets the indication for ICD therapy
- LVEF ≥ 30%
- Patient's compliance with protocol
- Signed patient informed consent form
Exclusion
- Patient meets one contraindication for ICD therapy
- Permanent atrial tachyarrhythmia
- Age \< 18 years
- Cardiac surgery planned within the next 6 months
- Life expectancy of less than 6 months
- Limited contractual capability
- Participating in another clinical study of an investigational cardiac drug or device
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2012
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01486836
Start Date
November 1 2011
End Date
September 1 2012
Last Update
September 12 2013
Active Locations (1)
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1
Charité Uniklinikum Benjamin Franklin
Berlin, Germany, 12200