跳至主要内容
临床试验/NCT07291544
NCT07291544已完成不适用

Management of Supraventricular Tachycardias in Children: A National Multicenter Study

Paris Cardiovascular Research Center (Inserm U970)0 个研究点目标入组 1,400 人开始时间: 2000年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,400
主要终点
Antiarrhythmic therapies

研究概览

简要总结

Background

Supraventricular tachycardias (SVTs) are the most common arrhythmic events in children, with an estimated incidence of 13 per 100,000 per year before the age of 18. Few large patient cohorts have been reported, as most published studies are single-center. Large-scale studies come from medico-administrative databases, which lack the granularity needed for detailed analysis of outcomes according to the therapies used and the type of SVT.

Furthermore, although a large proportion of neonatal SVTs do not recur (spontaneous resolution of the accessory pathway), there are limited comparative data on the effectiveness of antiarrhythmic therapies specifically in children after the age of 1 year. Management therefore varies greatly, in part because current guidelines propose different therapeutic options based on low-level evidence.

Objectives:

  • Describe the management of SVTs (antiarrhythmic therapies and catheter ablation) in children in France
  • Compare the effectiveness of different antiarrhythmic treatments according to age (<1 year and >1 year) and type of SVT
  • Analyze the incidence of adverse events and complications associated with antiarrhythmic treatments and catheter ablation

详细描述

INTRODUCTION

Supraventricular tachycardias (SVTs) represent the most frequent arrhythmic events in children, with an estimated incidence of 13 per 100,000 per year before the age of 18. This incidence is likely underestimated due to the often sporadic nature of symptoms and spontaneous resolution in a non-negligible proportion of patients.

Most SVTs in children are junctional tachycardias, particularly related to accessory pathways when symptoms begin before the age of 10. However, numerous different forms of SVT exist, with highly heterogeneous natural histories and prognoses. Few large patient cohorts have been reported, as most published studies are single-center. Larger-scale studies rely on medico-administrative databases, which lack sufficient granularity for a detailed analysis of outcomes based on the therapies implemented and the type of SVT.

Furthermore, although a large proportion of neonatal SVTs will not recur (due to spontaneous resolution of the accessory pathway), limited comparative data are available regarding the efficacy of antiarrhythmic therapies in children older than 1 year. Management is therefore highly variable, notably because current guidelines propose several therapeutic options supported by low-level evidence.

The aim of this study is to describe the epidemiology and management of SVTs in an unselected pediatric population across a broad network of centers in France, and to compare the efficacy of different therapies according to age and SVT type.

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
0 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age <18 years at the time of the first documented supraventricular tachycardia episode

排除标准

  • Early postoperative supraventricular tachycardia (<30 days)
  • Age ≥18 years at the first documented supraventricular tachycardia episode
  • Fetal tachycardias without postnatal recurrence
  • Atrial extrasystoles without sustained runs (<30 seconds)

结局指标

主要结局

Antiarrhythmic therapies

时间窗: At the time of the first supraventricular tachycardia recorded

Proportion of antiarrhythmic therapies used by age group (\<1 year and \>1 year)

Catheter ablation

时间窗: At the time of first episode of supraventricular tachycardia or after recurrence

Proportion of children referred for catheter ablation and age at ablation

Recurrence of supraventricular tachycardia

时间窗: At 1 year after antiarrhythmic drug initiation

Time between antiarrhythmic therapy initiation and first recurrence, according to treatment and age

次要结局

未报告次要终点

研究者

发起方
Paris Cardiovascular Research Center (Inserm U970)
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Victor WALDMANN

Head of pediatric and congenital electrophysiology

Paris Cardiovascular Research Center (Inserm U970)

相似试验