User Manual

Lumax Technical Manual 21
1.5.2.2 Tupos LV/ATx Study
NOTE:
The clinical study information included in this section and in
Section
1.6.2 was performed with the Tupos LV/ATx CRT-D,
which is an earlier version of the Lumax CRT-D/ICD families.
The clinical study data presented here is applicable because
the Lumax family are downsized versions of the
Tupos LV/ATx CRT-D and Tachos ICD families. The Lumax
family is slightly different as compared to the Tupos LV/ATx
(and Tachos family) in the following areas:
 Reduced size from 50/48 cc to 40/35 cc
 Addition of Home Monitoring® functionality
 Addition of triggered pacing for biventricular pacing
modes
 True three chamber pacing and sensing capabilities
(CRT-Ds)
The OPTION CRT/ATx study was a prospective, randomized,
multi-center study 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. All patients enrolled into
the clinical study were randomly assigned to either the study
group or the control group at a 2 to 1 ratio. Patients in the study
group were implanted with the Tupos LV/ATx. Patients in the
control group were implanted with a legally marketed ICD that
provides CRT.
Of the 278 adverse events reported in the Tupos LV/ATx study
group, there have been 210 observations in 104 patients and 68
complications in 50 patients with a cumulative implant duration of
1240.4 months (101.9 patient-years). 37.6% of the enrolled study
patients have experienced a complication. The rate of
complications per patient-year is 0.67. 78.2% of the enrolled
study patients have a reported observation. The rate of
observations per patient-year is 2.06.