跳至主要内容
临床试验/NCT05390047
NCT05390047招募中不适用

The International Subcutaneous Implantable Cardioverter Defibrillator Registry (iSuSi)

University of Luebeck1 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2022年7月1日最近更新:
适应症

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

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

发起方
University of Luebeck
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Roland Richard Tilz

Prof. Dr. med. Roland Richard Tilz

University of Luebeck

研究点 (1)

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