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临床试验/NCT04101253
NCT04101253已完成不适用

SCREENING FOR THE IMPLANTATION OF A SUBCUTANEOUS IMPLANTABLE AUTOMATIC DEFIBRILLATOR: OPTIMIZATION OF THE PROCEDURE BY REPOSITIONING THE ELECTRODES AND RESEARCH OF THE PREDICTIVE FACTORS OF FAILURE

Centre Hospitalier de PAU16 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2019年12月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
480
试验地点
16
主要终点
screening success rates

研究概览

简要总结

S-ICD (subcutaneous implantable cardioverter-defibrillator) screening failure occurs in about 10% of cases. Predictors of screening failure are not yet well determined. Moreover, slight variations in electrode positioning may change vector configuration and therefore improve screening success rates

详细描述

S-ICD (subcutaneous implantable cardioverter-defibrillator) has become the last years widespread in various pathological conditions and implantation rates are increasing each year worldwide. Previous to implantation it is mandatory to realize a screening in order to assess specific electrocardiographic vectors used to analyze cardiac rhythm. In routine practice, approximatively 10% of patients are recused for S-ICD device implantation due to failed screening 1-3. Causes are mainly abnormalities of R wave (low or high amplitude) and low R/T wave ratio. Determinants for screening failure have not yet been clearly studied. Moreover, it is a common finding in S-ICD implantation to find variations between pre-implant electrograms and electrograms recorded by the device. Variations of R wave amplitude and R/T ration are also observed with small variations of electrode positioning prior to implantation. It has been also shown that despite initial screening failure, S-ICD could be securely performed in some cases 4,5. Patients included in the study will undergo usual screening protocol. In case of failure a 2nd screening will be realize with slight electrode positioning variations compatible with S-ICD and lead placement. In case of success modality of implantation will be decided by physician.

In case of S-ICD implantation screening data will be compared to post implantation device electrograms. A 2 month follow-up will be performed with comparison of a new screening procedure with electrodes at the level of sub-cutaneous electrodes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The population will be composed of all patients referred for ICD method, aged over 18 years

排除标准

  • Age < 18 years old
  • Patients who cannot freely give their consent, or patients who refuse to participate

结局指标

主要结局

screening success rates

时间窗: one day

Comparison of success rates between the standard screening procedure (without repositioning the electrodes) and the proposed new procedure (small variations in electrode positioning)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (16)

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