Atrial Fibrillation on Holter Monitoring After Percutaneous Patent Foramen Ovale Closure : a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- occurrence of sustained supra-ventricular arrhythmia
研究概览
简要总结
An increased risk of atrial fibrillation (AF) after patent foramen ovale (PFO) closure was observed in randomized trials but systematic screening of AF was not performed in these studies. Purpose: The objective of this study was to evaluate incidence of AF in patients who underwent percutaneous PFO closure with serial 24-hours ambulatory ECG (AECG) monitoring during 6 months follow-up. Primary endpoint was incidence of AF on ECG monitoring. Secondary endpoints were clinical outcomes (symptoms, hospitalization from cardiovascular causes, ischemic stroke, or bleeding) up to 6 month follow-up.
详细描述
This is a prospective, bicentric, observational cohort study which will be performed in University hospital center of Montpellier and Nîmes The study will include all consecutive patients, admitted for a percutaneous PFO closure after an ischemic stroke (IS) or a transient ischemic attack (TIA) of cryptogenic origin, or after the occurrence of a decompression illness during scuba diving. Patients eligible for the closure of a FOP in prevention of the recurrence of stroke or TIA of cryptogenic origin, was systematically evaluated for exclusion of supraventricular arrhythmia in accordance with international recommendations. This evaluation included a 12-lead ECG as well as an extended electrocardiographic monitoring lasting more than or equal to 24 hours (most frequently, performing a 72-hour ECG Holter). All patients previously has a transesophageal ultrasound (TEE) allowing to retain the diagnosis of PFO, to assess the presence or not of an atrial septum aneurysm (ASA) associated with PFO and to quantify the right to left shunt thanks to a contrast test potentiated by a Valsalva maneuver. Exclusion criteria included interatrial defect with left to right and others indications for PFO closure that cryptogenic stroke or decompression illness. Indication of PFO closure is always validated by a cardio neurological team.
The primary objective of the study was incidence of AF defined as an irregular rhythm without discernible P waves lasting at least 30 seconds on ECG monitoring during the 6-month follow-up. The secondary objectives were to evaluate the characteristics of the supra-ventricular arrhythmias (delay in onset, duration, recurrent nature), incidence of others arrhythmia, symptoms, and prognostic implications of AF (hospitalization , need of curative anticoagulation, need for cardioversion and occurrence of neurological accident documented by imagery (ischemic stroke or TIA). The investigators also evaluated risk factors for occurrence of arrhythmia.
A total of 100 patients included during 1 year is expected
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women over the age of 18 to 60
- •Benefiting from the closure of the FOP percutaneously after a cryptogenic ischemic stroke or a TIA (indication validated during a multidisciplinary meeting with neurologists and cardiologists)
排除标准
- •Inability to perform a 24h ECG Holter
- •Pregnant or lactating women
- •Vulnerable people
结局指标
主要结局
occurrence of sustained supra-ventricular arrhythmia
时间窗: at 12 month
occurrence of sustained supra-ventricular arrhythmia (AF, atrial flutter) during the analysis at 12 month (Holter ECG)
次要结局
- hospitalization related to arrhythmia(24 hours post-intervention to 12 months)
- symptoms related to the arrhythmia episode(24 hours post-intervention to 12 months)
- characteristics of these detected arrhythmias(24 hours post-intervention to 12 months)
- occurrence of a neurological accident.(24 hours post-intervention to 12 months)