User Manual

50 Lumax Technical Manual
The primary endpoint hypothesis required that a high proportion
of subjects remain “not worsened” when CRT with V-V
programmability and optimization was delivered compared to
when CRT without V-V programmability and optimization. A high
proportion was defined according to an Objective Performance
Criteria (OPC), derived from observations of how often stable
subjects in the BIOTRONIK Tupos LV/ATX CRT-D trial (OPTION)
experienced spontaneous worsening due to the underlying
disease among other factors.
During the Lumax V-V clinical study, the V-V optimization was
completed utilizing echocardiography specifically determining an
optimal V-V delay using the velocity time integral (VTI) to non-
invasively measure stroke volume. The assessment was
performed by determining the V-V delay setting associated with
the largest VTI value. The VTI of the aortic flow is measured in
the apical 5 chamber view.
Prior to the V-V delay optimization procedure, each patient
underwent an optimization of AV timing. Following the AV timing
adjustment, this standardized procedure was followed for the
optimization of V-V delay:
1. Program the Lumax HF-T “Initially Paced Chamber”
parameter to either RV or LV based on preference.
2. Assess the VTI measurement at the following V-V delays
(additional V-V settings may be utilized at the investigator’s
discretion):
 100 ms
 80 ms
 60 ms
 40 ms
 20 ms
 0 ms
Note: Use the average VTI parameter over a 3 beat cycle and
wait 10 to 15 seconds between changing V-V delay settings.
Also, attempt to measure the VTI parameter within the same
patient respiratory cycle.
3. Record the VTI measurement associated with each V-V
delay setting
Repeat steps 1-3 for the remaining “Initially Paced Chamber”
parameters