DF4 Master Study (Safety and Efficacy Study)
NCT01790841 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 240
Last updated 2016-04-19
Summary
The purpose of the study is to proof the safety and efficacy of the new ICD sytem (Iforia/Ilesto). The devices are available with DF-1 and DF4 connection. A special focus is set on the ICD system with DF4 connection.
Conditions
- Ventricular Tachycardia
- Ventricular Fibrillation
- Sudden Cardiac Death
- Heart Failure
Interventions
- DEVICE
-
Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego
Sponsors & Collaborators
-
Biotronik SE & Co. KG
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-02-28
- Primary Completion
- 2015-05-31
- Completion
- 2016-04-30
Countries
- Germany
Study Locations
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