S-ICD Brugada: Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients

Sponsor

Nantes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02344277

Collaborator

(none)

130

Enrollment

Locations

47.4

Actual Duration (Months)

5.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brugada Syndrome S-ICD System (Implantable Defibrillator)	Device: S-ICD System (implantable defibrillator)

Study Design

Study Type:

Observational

Actual Enrollment :

130 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients

Actual Study Start Date :

May 12, 2015

Actual Primary Completion Date :

Apr 25, 2019

Actual Study Completion Date :

Apr 25, 2019

Outcome Measures

Primary Outcome Measures

appropriate number of shocks to the number of shocks recorded at 5 years after S-ICD implantation [5 years]
The primary endpoint is the rate of successful appropriate shocks recorded at 5 years after S-ICD implantation in Brugada syndrome patients. In this population that will be a mix of symptomatic and asymptomatic patients, we anticipate a 1.5% per year event rate that will allow us to have a total of 15 patients receiving an appropriate shock at the end of the study.

Secondary Outcome Measures

annual rate of inappropriate shocks [5 years]
The secondary end point will be the annual rate of inappropriate shocks, the complications of S-ICD implantation and the complications during the follow-up.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Copenhagen University Hospital	Copenhagen	Denmark	2100
2	Gentofte University Hospital	Gentofte	Denmark	2900
3	Bordeaux University Hospital	Bordeaux	France	33604
4	Brest University Hospital	Brest	France	29609
5	Grenoble University Hospital	Grenoble	France	38043
6	Lille University Hospital	Lille	France	59037
7	Hospices Civils de Lyon	Lyon	France	69394
8	AP-HM La Timone	Marseille	France	13005
9	Montpellier University Hospital	Montpellier	France	34295
10	Nancy University Hospital	Nancy	France	54511
11	Nantes University Hospital	Nantes	France	44093
12	AP-HP Hôpital BIchât	Paris	France	75018
13	Paris University Hospital - La pitié-Salpétrière	Paris	France	75651
14	Rennes University Hospital	Rennes	France	35033
15	La Réunion University Hospital	Saint-Pierre	France	97448
16	Strasbourg University Hospital	Strasbourg	France	67091
17	Toulouse University Hospital	Toulouse	France	31059
18	Tours University Hospital	Tours	France	37044
19	University Medical Centre Mannheim	Mannheim	Germany	D-68 167
20	University of Turin	Turin	Italy	10126
21	Hospital clinic de Barcelona	Barcelona	Spain	08036
22	Hospital Puerta de Hierro	Majadahonda	Spain	28222