The International Subcutaneous Implantable Cardioverter Defibrillator Registry (iSuSi)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Overall complication rate
研究概览
简要总结
The entirely subcutaneous implantable defibrillator (S-ICD) (Emblem, Boston Scientific, Marlborough, MA, USA) was introduced as a new therapeutic alternative to the conventional transvenous ICD in 2009 and implantations are rapidly expanding since then.1 Implantation of the S-ICD seems to reduce implant-related perioperative complications such as pneumothorax, hematoma and cardiac tamponade.
The aim of this multicenter registry is thus to assess the outcome of patients following an S-ICD implantation in a real-world setting.
详细描述
The S-ICD has a CE mark and is FDA approved since 2012 and is mentioned as a potential therapy strategy in the current AHA guidelines on the management of patients with ventricular arrhythmias.2 However, although implant-related complications seem to be reduced by the S-ICD in randomized controlled trials, the rate of inappropriate shocks remains high in S-ICD patients (10-13%).3-5 The most common reason for inappropriate shocks is cardiac oversensing, mostly due to T-wave oversensing or low amplitude of the subcutaneous signal, which not commonly found in patients with transvenous ICDs. Data on the role of the Defibrillation Threshold Testing (DFT), the rate of infectious complications (lead or device complications), the use of the S-ICD in children and adolescents, and the outcome of patients with an S-ICD according to their underlying cardiac substrate are sparse. The aim of this multicenter registry is thus to assess the outcome of patients following an S-ICD implantation in a real-world setting with a special focus on perioperative complication rate, the role of DFT testing in S-ICD, the use of the S-ICD in cohorts that are underrepresented in clinical studies (adolescents and geriatrics), the outcome and risk factors of ineffective, inappropriate and appropriate shocks and the differences in outcomes according to the underlying cardiac disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Implantation of an S-ICD, regardless of the technique
- •At least 1 month of follow up
- •At least 1 post-implantation assessment, in accordance to the routine clinical practice of every center (e.g. in person visit or remote follow up)
排除标准
- 未提供
结局指标
主要结局
Overall complication rate
时间窗: through study completion, an average of 2 years
combination of device related complications and inappropriate shocks
Rate of inappropriate shocks
时间窗: through study completion, an average of 2 years
Inappropriate therapies delivered by the devices
Rate of appropriate shocks
时间窗: through study completion, an average of 2 years
Appropriate therapies delivered by the devices
次要结局
- DFT impact(2 year)
- Device-related complication rate(immediately after the intervention/procedure/surgery")
- Role of Gender in primary outcomes(through study completion, an average of 2 year)
- Rate of device upgrades(through study completion, an average of 2 year)
- Rate of replacements(2 year)
研究者
Prof. Roland Richard Tilz
Prof. Dr. med. Roland Richard Tilz
University of Luebeck
