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临床试验/NCT04205461
NCT04205461Unknown不适用

Prospective Evaluation of Programmed Ventricular Stimulation Before Pulmonary Valve Replacement in Patients With Tetralogy of Fallot

Paris Cardiovascular Research Center (Inserm U970)1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Positive programmed ventricular stimulation defined as inducibility of sustained ventricular tachycardia or fibrillation

研究概览

简要总结

Severe pulmonary regurgitation is common in patients with Tetralogy of Fallot and results in progressive right ventricular dilatation and dysfunction. Pulmonary valve replacement is frequent in this population, and percutaneous procedures are increasing.

Ventricular arrhythmias are a frequent late complication in patients with tetralogy of Fallot. The most common critical isthmus of ventricular tachycardias is between the pulmonary valve and the ventricular septal defect patch.

While an electrophysiology study is sometimes performed in expert centers before surgical pulmonary valve replacement to guide a surgical ablation if needed, this approach is not recommended in current guidelines. An electrophysiology study should also be considered before percutaneous pulmonary valve replacement, as a part of the critical isthmus may be covered by the prosthetic pulmonary valve. Moreover, ablation after percutaneous pulmonary valve insertion exposes patients to the risks of traumatic valve or stent injury and infectious endocarditis.

At present, reliable predictors to identify high-risk patients in whom an electrophysiology study should be performed before pulmonary valve replacement are lacking.

The aim of this study is to assess prospectively the yield of systematic electrophysiology study and programmed ventricular stimulation before surgical and percutaneous pulmonary valve replacement in patients with tetralogy of Fallot.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients with repaired tetralogy of Fallot referred for surgical or percutaneous pulmonary valve replacement

排除标准

  • Absence of patient's consent

结局指标

主要结局

Positive programmed ventricular stimulation defined as inducibility of sustained ventricular tachycardia or fibrillation

时间窗: During ventricular programmed stimulation

Rate of sustained monomorphic or polymorphic ventricular tachycardia or ventricular fibrillation sustained \> 30 secondes during programmed ventricular stimulation

次要结局

  • Critical isthmus involved in ventricular tachycardias induced(During ventricular programmed stimulation)
  • Complications associated with programmed ventricular stimulation(1 month)
  • Rate of ventricular arrhythmias during the follow-up after pulmonary valve replacement(24 months)

研究者

发起方
Paris Cardiovascular Research Center (Inserm U970)
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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