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

Completed

• Conditions: Atrial Fibrillation; Arrhythmias, Cardiac

• Registration Number: NCT04991896
• Lead Sponsor: AHEPA University Hospital

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.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Study First Submitted: 2021-07-28
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-04
• Last Update Submitted: 2021-08-04
• Study First Posted: 2021-08-05
• Last Update Posted: 2021-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients converted to sinus rhythm at 1 hour	1 hour	Successful cardioversion from atrial fibrillation to sinus rhythm at 1 hour

Secondary Outcome Measures

Name	Time	Method
Number of arrhythmic events managed with defibrillation	2 hours	Any arrhythmic event managed with defibrillation
Hospitalization duration	48 hours	Total length of hospitalization duration in hours
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
Number of patients with documented severe hypotension	2 hours	Systolic blood pressure \<90 mmHg for \>10 min or requiring inotropic support
Number of patients with any documented proarrhythmic event	2 hours	Ventricular tachycardia, ventricular fibrillation, torsades de pointes, atrial flutter with 1:1 atrioventricular conduction

Trial Locations

Locations (1)

Skylitseio General Hospital; 🇬🇷 Chios, Greece