Clinical trial NCT04991896: Beta Blockers Plus Intravenous Flecainide for Paroxysmal Atrial Fibrillation: a Real-world Chios Registry (BETAFLEC-CHIOS)
Official title: Acute Management of Paroxysmal Atrial Fibrillation With Beta Blockers Plus Intravenous Flecainide: a Real-world Chios Registry (BETAFLEC-CHIOS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Arrhythmias, Cardiac
Lead sponsor: AHEPA University Hospital
Sponsor class: OTHER
Collaborators: name: Skylitseio General Hospital
First posted: 2021-08-05
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients converted to sinus rhythm at 1 hour
timeFrame: 1 hour
Secondary outcomes:
measure: Number of patients converted to sinus rhythm at 2 hour
timeFrame: 2 hours
measure: Number of patients with any documented proarrhythmic event
timeFrame: 2 hours
measure: Number of arrhythmic events managed with defibrillation
timeFrame: 2 hours
measure: Number of patients with documented severe hypotension
timeFrame: 2 hours
measure: Number of patients that discontinued IV flecainide infusion
timeFrame: 2 hours
measure: Hospitalization duration
timeFrame: 48 hours
Other outcomes:
Locations:
city: Chios
country: Greece
facility: Skylitseio General Hospital
Study officials:
affiliation: Skylitseio General Hospital of Chios
name: Athanasios Kartalis
role: PRINCIPAL_INVESTIGATOR
affiliation: AHEPA University General Hospital
name: Matthaios Didagelos
role: PRINCIPAL_INVESTIGATOR
References: