Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 22
- 主要终点
- appropriate number of shocks to the number of shocks recorded at 5 years after S-ICD implantation
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
appropriate number of shocks to the number of shocks recorded at 5 years after S-ICD implantation
时间窗: 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.
次要结局
- annual rate of inappropriate shocks(5 years)