130
Participants
Start Date
May 12, 2015
Primary Completion Date
April 25, 2019
Study Completion Date
April 25, 2019
S-ICD System (implantable defibrillator)
"The subjects will be symptomatic or asymptomatic Brugada patients with Indication for ICD replacement. Patients should be follow first at 1 month and then every 6 months according to the recent ACC/AHA/HRS guidelines60, for a period of 5 years until remote monitoring became available for S-ICD.~Visit to 4 week post-implantation: Vital status, Clinical assessment data: weight; height; blood pressure; NYHA class, Exercise test will be performed to control sensing vectors during exercise, Electrocardiogram, Current cardiac medication, Device interrogation, Device programming, Save to USB pen drive data + Printouts Adverse events, Life quality evaluation form. Visit every 6 months post-implantation to 5 years follow-up visit: Vital status, Clinical status (e.g.NYHA) , Electrocardiogram , Current cardiac medication, Device interrogation, Device programming, Save to USB pen drive data + Printouts Adverse events, Life quality evaluation form, Current status of S-ICD system."
Copenhagen University Hospital, Copenhagen
Gentofte University Hospital, Gentofte Municipality
University of Turin, Turin
AP-HM La Timone, Marseille
Hospital Puerta de Hierro, Majadahonda
Brest University Hospital, Brest
Toulouse University Hospital, Toulouse
Bordeaux University Hospital, Bordeaux
Montpellier University Hospital, Montpellier
Rennes University Hospital, Rennes
Tours University Hospital, Tours
Grenoble University Hospital, Grenoble
Nantes University Hospital, Nantes
Nancy University Hospital, Nancy
Lille University Hospital, Lille
Strasbourg University Hospital, Strasbourg
Hospices Civils de Lyon, Lyon
AP-HP Hôpital BIchât, Paris
Paris University Hospital - La pitié-Salpétrière, Paris
La Réunion University Hospital, Saint-Pierre
University Medical Centre Mannheim, Mannheim
Hospital clinic de Barcelona, Barcelona
Nantes University Hospital
OTHER