User Manual

Lumax Technical Manual 41
2. The purpose of Secondary Endpoint 2 is to evaluate VT
(ventricular tachycardia) and VF (ventricular fibrillation)
detection times of the Tupos LV/ATx. This is a measure of the
ability of the ventricular detection algorithm to detect VT and
VF in an appropriate timeframe. This endpoint was evaluated
based on the review of electrograms following induced VT/VF
episodes. A comparison of data from the TACT study that
utilized the legally marketed Tachos DR – Atrial Tx ICD
(P000009/S4, dated 09-09-2002) to data collected during the
OPTION study for the Tupos LV/ATx was performed.
Table 13
summarizes and compares the results from these
two clinical studies.
Table 13: Summary of Detection Times
Detection
Time
Tachos DR -
Atrial Tx ICD
Mean (SE)/N
Tupos
LV/ATx Mean
(SE)/N
Difference
Individual
Readings
2.27 (0.06)/52 2.26 (0.06)/71 0.01
By Patient 2.27 (0.07)/26 2.24 (0.06)/35 0.03
The analysis demonstrates that the average detection times
of the Tupos LV/ATx are comparable to the detection times
observed with the legally marketed Tachos DR - Atrial Tx
ICD. Both devices utilize identical ventricular detection
algorithms and only sense with the right ventricular lead. This
clinical data demonstrates that the ventricular detection times
are similar in both devices.
3. The purpose of Secondary Endpoint 3 is to evaluate the
percentage of ventricular pacing (thus, CRT) as
demonstrated by the device diagnostics at required follow-
ups. This data was based on diagnostic data stored by the
Tupos LV/ATx.
Table 14
summarizes the percentage of ventricular pacing
between follow-ups as shown by device diagnostics for
patients in the study group.