NCT00729235

Biventricular Tachycardias Outcome Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 481 (actual)
• Sponsor: LivaNova · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Biventricular Tachycardias

Interventions

Type	Name	Description
DEVICE	Ovatio CRT 6750	Slow VT zone programmed as a "Monitoring" zone (Monitoring arm)
DEVICE	Ovatio CRT 6750	Slow VT zone programmed with ATP therapies (therapy arm).

Timeline

• Start date: 2006-05-01
• Primary completion: 2008-12-01
• Completion: 2011-11-01
• First posted: 2008-08-07
• Last updated: 2011-12-22

Locations

49 sites across 9 countries: Belgium, Canada, France, Germany, Italy, Portugal, Spain, Sweden, United Kingdom