BETAFLEC-CHIOS
Acute Management of Paroxysmal Atrial Fibrillation With Beta Blockers Plus Intravenous Flecainide: a Real-world Chios Registry (BETAFLEC-CHIOS)
Sponsor study identifier
observational
81
1 country
1
Study Start
January 1, 2020
Actual (reported)Primary Completion
June 30, 2021
Actual (reported)Study Completion
June 30, 2021
Actual (reported)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".
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2021
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2020
Actual (reported)June 30, 2021
Actual (reported)June 30, 2021
Actual (reported)July 28, 2021
Actual (reported)August 5, 2021
Actual (reported)Number of patients converted to sinus rhythm at 1 hour
Successful cardioversion from atrial fibrillation to sinus rhythm at 1 hour
1 hour
Number of patients converted to sinus rhythm at 2 hour
2 hours
Number of patients with any documented proarrhythmic event
2 hours
Number of arrhythmic events managed with defibrillation
2 hours
Number of patients with documented severe hypotension
2 hours
Number of patients that discontinued IV flecainide infusion
2 hours
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Skylitseio General Hospital
Chios, 82100, Greece
Athanasios Kartalis
Skylitseio General Hospital of Chios
Matthaios Didagelos
AHEPA University General Hospital
81 participants (actual enrollment reported by the registry).
First Submitted
July 28, 2021
First Posted
August 5, 2021
Study Start
January 1, 2020
Actual (reported)Design and Rationale of the Assessment of the MindMics Recording System
Contact the study team to confirm eligibility.
Primary Completion
June 30, 2021
Actual (reported)Study Completion
June 30, 2021
Actual (reported)Last Updated
August 11, 2021
Record last verified: 2021-08
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Source: ClinicalTrials.gov.
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