Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients
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.
Inclusion Criteria:

 - Patient with type I Brugada syndrome eligible for implantation of an S-ICD system:

 Symptomatic : (history of resuscitated sudden death, syncope) with an ECG showing an aspect
 of Brugada syndrome type I before or after pharmacological tests (ajmaline or flecainide
 test) according to the criteria of the consensus conference and after ECG validation by the
 Clinical Events Committee experts.

 Asymptomatic: with an aspect of spontaneous type I Brugada syndrome after ECG validation by
 the Clinical Events Committee experts.

 -  Brugada syndrome patient with Indication for ICD replacement.

 -  No contra-indication for S-ICD implantation (anatomic or physiologic criteria) with
 particular attention to the validation of the ECG prescreening implantation. For this
 study at least 2 vectors must be suitable for S-ICD implantation.

 -  Patients whose age is 18 years or above, or of legal age to give informed consent
 specific to state and national law.

 -  Patients who are willing and capable of providing informed consent, participating in
 all testing associated with this clinical investigation at an approved clinical
 investigational center.

 Exclusion Criteria:

 -  Incessant ventricular tachycardia (VT) and/or documented spontaneous, frequently
 recurring VT that is reliably terminated with anti-tachycardia pacing.

 -  Patients with unipolar pacemakers or implanted devices that revert to unipolar pacing.

 -  Presence of any severe medical condition such that the patient is not expected to
 survive for the planned study follow-up period.

 -  Minor, patient under trusteeship or under guardianship.

 -  Patients who currently participate in an investigational drug or device that
 clinically interferes with the S-ICD-Brugada registry study endpoints and results.

 -  Female of childbearing potential without adequate contraception at the time of the
 implantation.

 -  Inability to comply with the follow-up schedule.