Biventricular Tachycardias Clinical Trial
Official title:
Biventricular Tachycardias Outcome Trial
This clinical investigation is a device-based open, prospective, multicenter two-arm
randomized trial, comparing patients who are treated in the slow VT zone versus patients who
are not treated in that zone.
The device intended to be used is the OVATIOTM CRT model 6750 but future generation of Sorin
Group/ ELA Medical devices may be used provided they are CE marked. Ethics committees and
health authorities will be informed prior to any use of a newer device if applicable.
All patients will have a 3-zone detection configuration programmed. The slow VT zone will be
defined by programming the detection parameters as follows:
- Slow VT detection rate: 100 bpm (or if the resting rate is higher than 80 bpm, we
recommend to adjust this parameter to: resting rate + 30 bpm)
- VT detection rate: 150 bpm
PARAD+ will be the first choice for SVT/ST and VT discrimination in the VT zones.
The Fast VT and VF limits are left to investigator's judgment. Therapy on VT, fast VT and VF
are also left to the investigator's judgment.
Patients will be randomized at implant to have the slow VT zone programmed as a monitoring
zone (monitoring arm) or to have therapies programmed within the slow VT zone (therapy arm).
The randomization table will be generated by Sorin Group/ELA Medical.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment