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临床试验/NCT03207373
NCT03207373终止不适用

Reproducibility and Validity of the Stress ECG Test for the Evaluation of the Risk of Sudden Cardiac Death in a Paediatric Cohort With Preexcitation (WPW Pattern)

Christian Balmer2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2017年4月13日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
3
试验地点
2
主要终点
Cycle length (CL) at the Stress ECG Test

研究概览

简要总结

Patients with preexcitation are at risk for sudden cardiac death. The pathogenesis is a rapid antegrade conduction of atrial fibrillation over the accessory pathway to the ventricle resulting in ventricular fibrillation. Today it is possible to eliminate the conduction over the accessory pathway by catheter intervention (radiofrequency ablation) with a low rate of complications and a high rate of success. In clinical practice it is therefore important to estimate the risk for sudden cardiac death in an individual patient to give an advice to the patient and the parents about the further evaluation and therapeutic strategy. The velocity of the conduction over the accessory pathway can be estimated by analysing the ECG during sinus tachycardia. If the preexcitation disappears at a relatively low heart rate, the risk for sudden death is less than in patients with persisting preexcitation at the maximal heart rate. Compared to the gold standard i.e. measurement of the refractory period of the accessory pathway during invasive electrophysiological study (EPS), the measurements at the stress ECG have been reported to be a relatively poor indicator for an elevated risk which may be explained by a high intraindividual variability of this test. This study is designed to define the clinical relevance of the stress ECG in paediatric patients with preexcitation (compared to the invasive electrophysiological study).

First Hypothesis:

The results of the 3 stress ECG-tests are reproducible in an individual patient.

Null hypothesis: there is no difference between the three measurements of cycle length during stress ECG. Alternate hypothesis: the difference between the three measurements of cycle length is > 10%.

Second Hypothesis:

There is a close correlation between the results at stress ECG and the results at the invasive electrophysiological Intervention.

详细描述

Single centre, interventional study. There will be no randomisation or blinding.

This study evaluates the stress ECG test as a non-invasive method of risk stratification in patients with WPW syndrome. For the non-invasive part a stress electrocardiogram on a treadmill is used. The invasive comparison is made with an electrophysiological study (EPS) in the catheterization laboratory. Nowadays the gold standard for measuring the antegrade effective refractory period of the accessory pathway is the invasive EPS.

Study category A; there is only a minimal risk and a minimal burden to the study participants; The stress ECG test is a recommended test for this specific patient group as indicated in international guidelines.

The responsible investigator at the single study site ensures that approval from an appropriately constituted Competent Ethics Committee (CEC), is sought for the clinical study.

Objectives: 1) The study seeks primarily to evaluate the reproducibility of the loss of the preexcitation in repetitive stress ECG test in paediatric patients with WPW pattern in the view of an accurate estimation of the individual risk for sudden cardiac death.

研究设计

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

入排标准

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

入选标准

  • Informed Consent as documented by signature (Appendix Informed Consent Form)
  • Preexcitation in resting ECG (WPW ECG Pattern)
  • Age between 8 and 18 years
  • Invasive EPS must be indicated/planned at the Children's Hospital Zurich

排除标准

  • Inability to follow the procedures of the study, e.g. due to language problems or psychological disorders of the participant
  • Inability to walk/run on a treadmill

结局指标

主要结局

Cycle length (CL) at the Stress ECG Test

时间窗: 3 test within a month

Cycle length (ms) at the point when the delta wave disappears and/or at the point of maximal heart rate (HR) (ms)

次要结局

  • Anatomical localisation of the AP measured in the EPS(1 single measurement at aprox 1 month)
  • SPERRI from invasive EPS(1 single measurement at aprox 1 month)
  • ERP-AP from invasive EPS(1 single measurement at aprox 1 month)

研究者

发起方
Christian Balmer
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Christian Balmer

Head of Electrophysiology, principal investigator, clinical lecturer

University Children's Hospital, Zurich

研究点 (2)

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