Status:
COMPLETED
Lumax 740 Master Study
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Safety and Efficacy of the Lumax 740 ICD Family
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this study is to prove the safety and efficacy of the Lumax 740 ICD family. Primarily, the newly implemented RV/LV Capture Control algorithm is evaluated, which automatically measures...
Eligibility Criteria
Inclusion
- Standard indication for single, dual, or triple chamber ICD.
- Legal capacity and ability to consent
- Signed patient informed consent
- In addition for HF-T devices:
- Bipolar LV-lead with a min. distance of 15 mm between tip and ring
- True bipolar RV lead
Exclusion
- Standard contraindication for single, dual, or triple chamber ICD.
- Age \< 18 years
- Pregnant or breast-feeding woman
- Cardiac surgery planned within the next 6 months
- Life expectancy of less than 6 months
- Participating in any other clinical study of an investigational cardiac drug or device
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT01454050
Start Date
November 1 2011
End Date
November 1 2012
Last Update
November 28 2012
Active Locations (1)
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1
Medical School Hannover
Hanover, Germany, 30625