Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients

CompletedOBSERVATIONAL
Enrollment

130

Participants

Timeline

Start Date

May 12, 2015

Primary Completion Date

April 25, 2019

Study Completion Date

April 25, 2019

Conditions
Brugada SyndromeS-ICD System (Implantable Defibrillator)
Interventions
DEVICE

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."

Trial Locations (22)

2100

Copenhagen University Hospital, Copenhagen

2900

Gentofte University Hospital, Gentofte Municipality

10126

University of Turin, Turin

13005

AP-HM La Timone, Marseille

28222

Hospital Puerta de Hierro, Majadahonda

29609

Brest University Hospital, Brest

31059

Toulouse University Hospital, Toulouse

33604

Bordeaux University Hospital, Bordeaux

34295

Montpellier University Hospital, Montpellier

35033

Rennes University Hospital, Rennes

37044

Tours University Hospital, Tours

38043

Grenoble University Hospital, Grenoble

44093

Nantes University Hospital, Nantes

54511

Nancy University Hospital, Nancy

59037

Lille University Hospital, Lille

67091

Strasbourg University Hospital, Strasbourg

69394

Hospices Civils de Lyon, Lyon

75018

AP-HP Hôpital BIchât, Paris

75651

Paris University Hospital - La pitié-Salpétrière, Paris

97448

La Réunion University Hospital, Saint-Pierre

D-68 167

University Medical Centre Mannheim, Mannheim

08036

Hospital clinic de Barcelona, Barcelona

All Listed Sponsors
lead

Nantes University Hospital

OTHER

NCT02344277 - Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients | Biotech Hunter | Biotech Hunter