An observational study in Brugada Syndrome and S-ICD System (Implantable Defibrillator), sponsored by Nantes University Hospital. Completed at 22 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-29.
Sponsored by Nantes University Hospital · Observational
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.
53 studies on the registry are indexed under Brugada Syndrome; 18 are open to participants now.
This study's enrollment of 130 is below the median of 150 across 33 observational studies indexed under Brugada Syndrome.
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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.
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- 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.
Exclusion Criteria:
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.
appropriate number of shocks to the number of shocks recorded at 5 years after S-ICD implantation
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.
Time frame: 5 years
annual rate of inappropriate shocks
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.
Time frame: 5 years
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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