Arrhythmias, Cardiac, Atrial Fibrillation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGFlecainide Injectable Product
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.
Sponsors
Skylitseio General Hospital
AHEPA University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Informed written consent. 2. Recent-onset atrial fibrillation (AF) (≤48 hours of onset) and lasting ≥30min, documented by a 12-lead ECG 3. Administration of intravenous flecainide 4. Administration of an oral b-blocker
Exclusion criteria
1. Age \<18 years 2. Severe structural or ischemic heart disease (previous cardiac surgery, any cardiomyopathy, myocardial infarction at any time) 3. Atrial flutter, sick sinus syndrome, high degree atrioventricular block, bifascicular block 4. Abnormal electrolyte levels (especially hypo- or hyperkalemia) 5. Known sensitivity to flecainide
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients converted to sinus rhythm at 1 hour | 1 hour | Successful cardioversion from atrial fibrillation to sinus rhythm at 1 hour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with any documented proarrhythmic event | 2 hours | Ventricular tachycardia, ventricular fibrillation, torsades de pointes, atrial flutter with 1:1 atrioventricular conduction |
| Number of arrhythmic events managed with defibrillation | 2 hours | Any arrhythmic event managed with defibrillation |
| Number of patients converted to sinus rhythm at 2 hour | 2 hours | Successful cardioversion from atrial fibrillation to sinus rhythm at 2 hours |
| Number of patients that discontinued IV flecainide infusion | 2 hours | Discontinuation of the IV flecainide infusion for any reason |
| Hospitalization duration | 48 hours | Total length of hospitalization duration in hours |
| Number of patients with documented severe hypotension | 2 hours | Systolic blood pressure \<90 mmHg for \>10 min or requiring inotropic support |
Countries
Greece
Outcome results
None listed