Brugada Syndrome Clinical Trial
Official title:
Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients
Brugada syndrome is an inherited arrhythmia syndrome with an increased risk of syncope and
sudden death resulting from episodes of polymorphic ventricular tachychardia and
fibrillation. Currently, there is no medical therapy for the Brugada syndrome and the only
treatment available is the implantation of an ICD. There is no discussion on the interest of
the ICD implantation in secondary prevention and in patients who experienced syncope but the
best therapeutic is more difficult to draw in asymptomatic patients. Recently we demonstrated
that in asymptomatic patients with a spontaneous type 1 aspect of Brugada syndrome, (i) there
was a significant risk of ventricular arrhythmia, (ii) the problem of inappropriate shocks
can be solve with a good ICD programming and (iii) the problem of lead failure remains the
main problem in this young population very active and represent the main limitation to larger
indication of ICD implantation in this population with a very long life expectancy as these
patients had a normal life expectancy except the risk of ventricular arrhythmia.
In this context the S-ICD System (Boston Scientific Inc.) which is an implantable
defibrillator technology that treats ventricular tachyarrhythmias using a subcutaneous pulse
generator and electrode system rather than a transvenous lead system, represents a very
attractive opportunity as it gives the possibility to protect the patients of the risk of
ventricular arrhythmia with no risk of lead failure. However, as this is a new technology and
as Brugada syndrome patients are a very specific population (very active patients, specific
and changing over time ECG aspect that is at risk of T wave over sensing and high risk of
SVT), it seems important to evaluate the effectiveness and the safety of S-ICD in this
specific context.
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