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

Atrial Fibrillation Clinical Trial

— BETAFLEC-CHIOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04991896
• Other study ID #: 80-28/07/2021
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2021
• Source: AHEPA University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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".

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation

Intervention

Drug:
• Flecainide 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.

Locations

Country	Name	City	State
Greece	Skylitseio General Hospital	Chios

Sponsors (2)

Lead Sponsor	Collaborator
AHEPA University Hospital	Skylitseio General Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients converted to sinus rhythm at 1 hour	Successful cardioversion from atrial fibrillation to sinus rhythm at 1 hour	1 hour
Secondary	Number of patients converted to sinus rhythm at 2 hour	Successful cardioversion from atrial fibrillation to sinus rhythm at 2 hours	2 hours
Secondary	Number of patients with any documented proarrhythmic event	Ventricular tachycardia, ventricular fibrillation, torsades de pointes, atrial flutter with 1:1 atrioventricular conduction	2 hours
Secondary	Number of arrhythmic events managed with defibrillation	Any arrhythmic event managed with defibrillation	2 hours
Secondary	Number of patients with documented severe hypotension	Systolic blood pressure <90 mmHg for >10 min or requiring inotropic support	2 hours
Secondary	Number of patients that discontinued IV flecainide infusion	Discontinuation of the IV flecainide infusion for any reason	2 hours
Secondary	Hospitalization duration	Total length of hospitalization duration in hours	48 hours