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临床试验/NCT03572881
NCT03572881Unknown不适用

Assessment of Rhythmic Risk in Patients With Type 1 Brugada Syndrome by Pulmonary Infundibulum Mapping

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
1
主要终点
Identification of different voltage zones by endocardial mapping of the pulmonary infundibulum between asymptomatic patients with Brugada type 1 and patients with symptomatic Brugada type 1

研究概览

简要总结

Brugada syndrome has been described as the association of a right bundle block with ST segment elevation on the V1 to V3 electrocardiogram in patients with a structurally normal heart. The rhythmic risk is thus difficult to evaluate in asymptomatic patients in whom the rate of events is estimated at 0.2 to 1.4% of events per year. In addition, the predictive value of ventricular pacing remains controversial; There is therefore currently no review to effectively assess rhythmic risk in patients with Brugada type I syndrome.

Investigators aimed to show a difference in pulmonary infundibulum voltage mapping in symptomatic and asymptomatic patients with Brugada type 1 syndrome with a comparable ECG.

The mapping of the pulmonary infundibulum will be performed during electrophysiological exploration. Only the catheter used differs from the usual procedure.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Brugada Type 1 syndrome
  • Age : 50-60 years old
  • Asymptomatic
  • Signed informed consent
  • Brugada Type 1 syndrome
  • Age >18 years old
  • Implantable defibrillator
  • Having received at least 1 appropriate shock or a sudden sudden death
  • Signed informed consent
  • Groups 1 and 2

排除标准

  • Brugada Type 2 or 3 syndrome
  • Contraindication to electrophysiological exploration

结局指标

主要结局

Identification of different voltage zones by endocardial mapping of the pulmonary infundibulum between asymptomatic patients with Brugada type 1 and patients with symptomatic Brugada type 1

时间窗: Day 1

The voltage zone are defined with : * measurement of unipolar and bipolar local voltage (mV) * the scar surface * the surface of the bordering area * the surface of healthy tissue * the quantification of the number of fractionated potentials and density with respect to the size of the infundibulum and the scar (if present) * the analysis of the heterogeneity of the voltage (study of dispersion) * analysis of propagation card velocities in sinus rhythm and ventricular pacing (mm / s) * analysis of ventricular arrhythmia activation if positive ventricular pacing and good hemodynamic tolerance (focal / reentrant / reentrant macro).

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 (1)

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