Clinical trial NCT02344277: Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients
Official title: Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brugada Syndrome
S-ICD System (Implantable Defibrillator)
Keywords: Subcutaneaous Implantable Cardiac Defibrillator
Brugada syndrome
Effectiveness
Safety
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2015-01-22
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects selected for participation will be symptomatic or asymptomatic Brugada patients and, implanted or not with any ICD. Site investigators are responsible for screening. Subjects must meet all inclusion criteria. Subjects with any exclusion criteria will be excluded. The recruitment of the patients will be performed in a selected number of centers specifically involved in the management of patients affected by the Brugada syndrome in Europe and in which databases of patients are available.

Brief 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 criteria: 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.

Primary outcomes:
measure: appropriate number of shocks to the number of shocks recorded at 5 years after S-ICD implantation
timeFrame: 5 years
Secondary outcomes:
measure: annual rate of inappropriate shocks
timeFrame: 5 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital
city: Gentofte
country: Denmark
facility: Gentofte University Hospital
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Brest
country: France
facility: Brest University Hospital
city: Grenoble
country: France
facility: Grenoble University Hospital
city: Lille
country: France
facility: Lille University Hospital
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: AP-HM La Timone
city: Montpellier
country: France
facility: Montpellier University Hospital
city: Nancy
country: France
facility: Nancy University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Paris
country: France
facility: AP-HP Hôpital BIchât
city: Paris
country: France
facility: Paris University Hospital - La pitié-Salpétrière
city: Rennes
country: France
facility: Rennes University Hospital
city: Saint-Pierre
country: France
facility: La Réunion University Hospital
city: Strasbourg
country: France
facility: Strasbourg University Hospital
city: Toulouse
country: France
facility: Toulouse University Hospital
city: Tours
country: France
facility: Tours University Hospital
city: Mannheim
country: Germany
facility: University Medical Centre Mannheim
city: Turin
country: Italy
facility: University of Turin
city: Barcelona
country: Spain
facility: Hospital clinic de Barcelona
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro
Study officials:
affiliation: Nantes University Hospital
name: Vincent PROBST, Pr
role: PRINCIPAL_INVESTIGATOR
References: