User Manual

4 Lumax Technical Manual
BIOTRONIK conducted the TRUST study to evaluate the safety
and effectiveness of Home Monitoring, which is available in most
models of this device. Refer to Section 1.6.4 for details regarding
the study design and
results. With the TRUST study,
BIOTRONIK was able to show the following with regards to Home
Monitoring:
 BIOTRONIK Home Monitoring information may be used as a
replacement for device interrogation during in-office follow-up
visits.
 A strategy of care using BIOTRONIK Home Monitoring with
office visits when needed has been shown to extend the time
between routine, scheduled in-office follow-ups of
BIOTRONIK implantable devices in many patients. Home
Monitoring data is helpful in determining the need for
additional in-office follow-up.
 BIOTRONIK Home Monitoring-patients—who are followed
remotely with office visits when needed—have been shown to
have similar numbers of strokes, invasive procedures and
deaths as patients followed with conventional in-office
follow-ups.
 BIOTRONIK Home Monitoring provides early detection of
arrhythmias.
 BIOTRONIK Home Monitoring provides early detection of
silent, asymptomatic arrhythmias.
 Automatic early detection of arrhythmias and device system
anomalies by BIOTRONIK Home Monitoring allows for earlier
intervention than conventional in-office follow-ups.
 BIOTRONIK Home Monitoring allows for improved access to
patient device data compared to conventional in-office
follow-ups since device interrogation is automatically
scheduled at regular intervals.
1.2 Indications and Usage
The Lumax CRT-Ds are indicated for use in patients with all of the
following conditions:
 Indicated for ICD therapy
 Receiving optimized and stable Congestive Heart Failure
(CHF) drug therapy
 Symptomatic CHF (NYHA Class III/IV and LVEF  35%);
and