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

NCT04991896 | Completed

• 1 other identifier: 80-28/07/2021
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

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".

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Outcome Measures

Primary Outcomes (1)

• Number of patients converted to sinus rhythm at 1 hour

  Successful cardioversion from atrial fibrillation to sinus rhythm at 1 hour

  1 hour

Secondary Outcomes (6)

• 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

Interventions

Flecainide Injectable Product DRUG

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.

Also known as: Sotalol, Bisoprolol, Metoprolol, Betaxolol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Informed written consent.
• Recent-onset atrial fibrillation (AF) (≤48 hours of onset) and lasting ≥30min, documented by a 12-lead ECG
• Administration of intravenous flecainide
• Administration of an oral b-blocker

You may not qualify if:

• Age \<18 years
• 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)
• Known sensitivity to flecainide

Sponsors & Collaborators

• AHEPA University Hospital: lead
• Skylitseio General Hospital: collaborator

Study Sites (1)

Skylitseio General Hospital

Chios, 82100, Greece

Location

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Interventions

Sotalol; Bisoprolol; Metoprolol; Betaxolol

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenoxypropanolamines; Propanolamines; Propanols

Study Officials

• Athanasios Kartalis

  Skylitseio General Hospital of Chios

  PRINCIPAL INVESTIGATOR

• Matthaios Didagelos

  AHEPA University General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Consultant Cardiologist

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 5, 2021
• Study Start: January 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: August 11, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)