Last updated on February 2019

Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients


Brief description of study

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.

Clinical Study Identifier: NCT02344277

Contact Investigators or Research Sites near you

Start Over

Jacob Tfelt-Hansen, Pr

Copenhagen University Hospital
Copenhagen, Denmark
  Connect »

Michael Vinther, Pr

Gentofte University Hospital
Gentofte, Denmark
  Connect »

Frédéric SACHER, Pr

Bordeaux University Hospital
Bordeaux, France
  Connect »

Jacques MANSOURATI, Pr

Brest University Hospital
Brest, France
  Connect »

Pascal DEFAYE, Pr

Grenoble University Hospital
Grenoble, France
  Connect »

Salem Kacet, Pr

Lille University Hospital
Lille, France
  Connect »

Philippe CHEVALIER, Pr

Hospices Civils de Lyon
Lyon, France
  Connect »

Jean-Claude DEHARO, Pr

AP-HM La Timone
Marseille, France
  Connect »

Pasquié Jean-Luc, Pr

Montpellier University Hospital
Montpellier, France
  Connect »

Hugues BLANGY, Pr

Nancy University Hospital
Nancy, France
  Connect »

Vincent PROBST, Pr

Nantes University Hospital
Nantes, France
  Connect »

Antoine LEENHARDT, Pr

AP-HP H pital BIch t
Paris, France
  Connect »

Nicolas Badenco, Pr

Paris University Hospital - La piti -Salp tri re
Paris, France
  Connect »

Philippe MABO, Pr

Rennes University Hospital
Rennes, France
  Connect »

Gaël CLERICI, Dr

La R union University Hospital
Saint-Pierre, France
  Connect »

Laurence JESEL-MOREL, Dr

Strasbourg University Hospital
Strasbourg, France
  Connect »

Jean-Philippe MAURY, Dr

Toulouse University Hospital
Toulouse, France
  Connect »

Dominique BABUTY, Pr

Tours University Hospital
Tours, France
  Connect »

Martin BORGGREFE, Pr

University Medical Centre Mannheim
Mannheim, Germany
  Connect »

Fiorenzo Gaita, Pr

University of Turin
Turin, Italy
  Connect »

Josep BRUGADA TERRADELLAS, Pr

Hospital clinic de Barcelona
Barcelona, Spain
  Connect »

Fernandez Lozano Ignacio, Dr

Hospital Puerta de Hierro
Majadahonda, Spain
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.