New TRUST trial data confirms clinical benefits of home cardiac
5 September 2009
Biotronik SE & Co. KG has announced that new data from the TRUST
trial  presented at the European Society of Cardiology Congress 2009
demonstrates the benefits of the Biotronik Home Monitoring system in the
early detection of patient clinical events as well as the safe reduction
of in-office follow-up visits.
Biotronik Home Monitoring is a wireless, mobile remote monitoring
system for patients with implantable cardiac devices. The new data from
the TRUST trial reported that Biotronik Home Monitoring can safely and
effectively replace conventional in-office device follow-up visits.
Patients can be monitored safely through the Biotronik Home Monitoring
wireless system with only one annual in-office visit .
The TRUST trial also concluded that Biotronik Home Monitoring with
automatic daily surveillance provides early detection and notification
of both symptomatic and asymptomatic arrhythmic events, enabling earlier
Patients were evaluated earlier by their physician when significant
changes occurred in their implanted devices or clinical condition.
Remote monitoring event notifications were evaluated in a median of 3
days compared to more than 30 days with conventional care .
Moreover, the trial showed that the event notifications generated
from the Biotronik Home Monitoring system provided accurate information,
even for silent clinical events (eg asymptomatic atrial fibrillation) of
which the patients were unaware . At the same time, despite daily
remote monitoring, the event notifications were triggered infrequently
and do not overburden physicians’ or clinic resources with unnecessary
or distracting information.
“There has been a call from the medical community for remote
monitoring of patients with implantable cardiac devices. TRUST is the
first prospective large scale (1,443 patients) clinical trial to test
this technology. TRUST demonstrated that Biotronik Home Monitoring,
which is an advanced automatic remote monitoring system, can streamline
hospital visits and enhance surveillance for important device- or
patient-related clinical data. These results have important implications
for improved patient safety,” said Niraj Varma, MD, PhD, TRUST Principal
Investigator, Cleveland Clinic, Cleveland, Ohio, USA.
About the TRUST Trial
Developed by a steering committee of electrophysiologists and
cardiologists, with 1,443 patients enrolled from 105 North American
sites, TRUST (Lumos-T Safely Reduces Routine Office Device Follow Up) is
the first and largest study to test remote monitoring and rapid
detection of symptomatic and asymptomatic cardiac events in a
prospective, randomized trial. The study used BIOTRONIK Home Monitoring,
an automatic, fully wireless system that performs daily telemetric
surveillance of the patient and the technical status of the implanted
device, without requiring patient activation.
1. N. Varma et al. Evaluation of efficacy and safety of remote
monitoring for ICD follow-up: the TRUST trial. Circulation
2008;118;2309-2317, Abstract 4078.
2. N. Varma et al. Efficiency of calendar based ICD checks:
conventional follow-up compared to remote monitoring in the TRUST trial.
ESC Congress, Barcelona, Spain, August 30, 2009, Abstract 86114.
3. N. Varma et al. Event notification by remote monitoring systems
performing automatic daily checks: load, characteristics and clinical
utility. ESC Congress, Barcelona, Spain, August 31, 2009, Abstract
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