Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients

Status: Completed
Location: See all (22) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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.

Locations
Other Locations
Denmark
Copenhagen University Hospital
Copenhagen
Gentofte University Hospital
Gentofte
France
Bordeaux University Hospital
Bordeaux
Brest University Hospital
Brest
Grenoble University Hospital
Grenoble
Lille University Hospital
Lille
Hospices Civils de Lyon
Lyon
AP-HM La Timone
Marseille
Montpellier University Hospital
Montpellier
Nancy University Hospital
Nancy
Nantes University Hospital
Nantes
AP-HP Hôpital BIchât
Paris
Paris University Hospital - La pitié-Salpétrière
Paris
Rennes University Hospital
Rennes
La Réunion University Hospital
Saint-pierre
Strasbourg University Hospital
Strasbourg
Toulouse University Hospital
Toulouse
Tours University Hospital
Tours
Germany
University Medical Centre Mannheim
Mannheim
Italy
University of Turin
Turin
Spain
Hospital clinic de Barcelona
Barcelona
Hospital Puerta de Hierro
Majadahonda
Time Frame
Start Date: May 12, 2015
Completion Date: April 25, 2019
Participants
Target number of participants: 130
Authors
Sponsors
Leads: Nantes University Hospital

This content was sourced from clinicaltrials.gov

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