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临床试验/NCT04991896
NCT04991896已完成不适用

Acute Management of Paroxysmal Atrial Fibrillation With Beta Blockers Plus Intravenous Flecainide: a Real-world Chios Registry (BETAFLEC-CHIOS)

AHEPA University Hospital1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2020年1月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
81
试验地点
1
主要终点
Number of patients converted to sinus rhythm at 1 hour

研究概览

简要总结

BETAFLEC-CHIOS, is a single-center registry that was initiated in the "Skylitseion" General Hospital of Chios in January 2020 and is ongoing. The inclusion criterion is IV flecainide administration for recent-onset AF lasting less than 48 hours. Oral b-blockers are co-administered in all patients. The main exclusion criteria are severe structural or ischemic heart disease and conduction system dysfunction. Continuous monitoring is applied during and after administration of IV flecainide. If no conversion to sinus rhythm is achieved at 2 hours after flecainide infusion, the patient is recorded as "unsuccessful conversion attempt".

详细描述

Patient population BETAFLEC-CHIOS, is a single-center registry that was initiated in the "Skylitseion" General Hospital of Chios in January 2020 and is ongoing. Patients are included in the registry if presenting with recent-onset atrial fibrillation (AF) (≤48 hours of onset) and lasting ≥30min, documented by a 12-lead ECG and having received intravenous (IV) flecainide on treating physician's discretion. Exclusion criteria are severe structural or ischemic heart disease (previous cardiac surgery, any cardiomyopathy, myocardial infarction at any time), atrial flutter, sick sinus syndrome, high degree atrioventricular block, bifascicular block, abnormal electrolyte levels (especially hypo- or hyperkalemia) or known sensitivity to flecainide. Continuous monitoring is applied during and after administration of IV flecainide. If no conversion to sinus rhythm is achieved at 2 hours after flecainide infusion initiation, the patient is recorded as "unsuccessful conversion attempt" and forwarded for direct current cardioversion (DCC). All patients were anticoagulated according to the current European Society Guidelines (ESC) or the management of AF [ESC Afib 2020].

Flecainide administration Flecainide is given as an IV infusion of 1.5 mg/kg (max 150 mg) in DW 5% over 10 min under continuous monitoring. Concomitant administration of a b-blocker is also applied in all patients. The dose and type of b-blocker are selected according to heart rate during the AF and patient's medical history. "Time to conversion" is calculated as the time interval from the end of the infusion up to when sinus rhythm is observed on the monitor and confirmed subsequently with a 12-lead ECG.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Informed written consent.
  • Recent-onset atrial fibrillation (AF) (≤48 hours of onset) and lasting ≥30min, documented by a 12-lead ECG
  • Administration of intravenous flecainide
  • Administration of an oral b-blocker

排除标准

  • Age <18 years
  • Severe structural or ischemic heart disease (previous cardiac surgery, any cardiomyopathy, myocardial infarction at any time)
  • Atrial flutter, sick sinus syndrome, high degree atrioventricular block, bifascicular block
  • Abnormal electrolyte levels (especially hypo- or hyperkalemia)
  • Known sensitivity to flecainide

结局指标

主要结局

Number of patients converted to sinus rhythm at 1 hour

时间窗: 1 hour

Successful cardioversion from atrial fibrillation to sinus rhythm at 1 hour

次要结局

  • Number of arrhythmic events managed with defibrillation(2 hours)
  • Hospitalization duration(48 hours)
  • Number of patients that discontinued IV flecainide infusion(2 hours)
  • Number of patients converted to sinus rhythm at 2 hour(2 hours)
  • Number of patients with documented severe hypotension(2 hours)
  • Number of patients with any documented proarrhythmic event(2 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthaios Didagelos

Principal Investigator, Consultant Cardiologist

AHEPA University Hospital

研究点 (1)

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