Ovatio VR 6250 or DR6550
DeviceThe study requires the implantation of locally approved material:
- A right ventricular defibrillation lead
- In case of use of a dual chamber ICD a right atrial pacing lead
- A single chamber or dual chamber ICD manufactured by SORIN Group. At begin of the study this will be OVATIO VR model 6250 and OVATIO DR model 6550. Any new devices of same type manufactured by SORIN Group which will become locally approved during the conduction of the trial can be used in the study.
Holter recording will be performed with a market approved recording system allowing high resolution ECG recording compatible with the analysis software for TVar.