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NCT Number: NCT04991896

Beta Blockers Plus Intravenous Flecainide for Paroxysmal Atrial Fibrillation: a Real-world Chios Registry (BETAFLEC-CHIOS)

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".

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Skylitseio General Hospital

Chios, 82100, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Flecainide Injectable Product

Drug

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.

Other names: Sotalol, Bisoprolol, Metoprolol, Betaxolol

Primary outcomes

  1. Number of patients converted to sinus rhythm at 1 hour

    Time frame: 1 hour

    Successful cardioversion from atrial fibrillation to sinus rhythm at 1 hour

Secondary outcomes

  1. Number of patients converted to sinus rhythm at 2 hour

    Time frame: 2 hours

    Successful cardioversion from atrial fibrillation to sinus rhythm at 2 hours

  2. Number of patients with any documented proarrhythmic event

    Time frame: 2 hours

    Ventricular tachycardia, ventricular fibrillation, torsades de pointes, atrial flutter with 1:1 atrioventricular conduction

  3. Number of arrhythmic events managed with defibrillation

    Time frame: 2 hours

    Any arrhythmic event managed with defibrillation

  4. Number of patients with documented severe hypotension

    Time frame: 2 hours

    Systolic blood pressure <90 mmHg for >10 min or requiring inotropic support

  5. Number of patients that discontinued IV flecainide infusion

    Time frame: 2 hours

    Discontinuation of the IV flecainide infusion for any reason

  6. Hospitalization duration

    Time frame: 48 hours

    Total length of hospitalization duration in hours

Sponsors and collaborators

Lead sponsor

AHEPA University Hospital

Other

Collaborators

  • Skylitseio General Hospital

Registry information

Official study title

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

Acronym: BETAFLEC-CHIOS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 5, 2021
Registry last updated
Aug 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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