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Stratos LV/LV-T Technical Manual 49
The freedom from Stratos LV system-related and procedure-
related complications was 87.2% with a one sided lower 95%
confidence bound of 82.09%. Therefore, the null hypothesis was
rejected, and it was concluded that the complication-free rate at
6 months is equivalent to 85% within 10% and the primary safety
endpoint was met (p = 0.0002)
*
.
1.7.4 Tupos LV/ATx Clinical IDE Study -
OPTION CRT/ATx
The CRT functionality of the Stratos CRT-P devices is based on
the FDA approved Tupos LV/ATx. Therefore, the data from the
OPTION CRT/ATx study supports the effectiveness of CRT.
The OPTION CRT/ATx study was conducted on the Tupos
LV/ATx, a device that delivers CRT but, in addition, also offers
defibrillation therapy (CRT-D).
Study Design
The purpose of the prospective, randomized, multi-center
OPTION CRT/ATx study was to demonstrate the safety and
effectiveness of the investigational Tupos LV/ATx Cardiac
Resynchronization Therapy Defibrillator (CRT-D) in patients with
congestive heart failure (CHF) and atrial tachyarrhythmias.
Patients in the study group were implanted with a BIOTRONIK
Tupos LV/ATx. Patients in the control group were implanted with
any legally marketed CRT-D. Patients in both the study and
control groups were implanted with a legally marketed left
ventricular lead.
*
p value is provided for informational purposes to show trends only; clinical
significance is not indicated by p values for analyses that were not prespecified.