Actively Recruiting
Safety and Efficacy of Flecainide Versus Amiodarone for Cardioversion of Paroxysmal Atrial Fibrillation in Patients With Coronary Artery Disease Without Residual Ischemia and Ejection Fraction Over 35%
Led by Hippocration General Hospital · Updated on 2025-06-13
80
Participants Needed
3
Research Sites
4 weeks
Total Duration
On this page
Sponsors
H
Hippocration General Hospital
Lead Sponsor
W
Win Medica
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of two antiarrhythmic drugs, flecainide and amiodarone, for cardioversion of paroxysmal atrial fibrillation in patients with coronary artery disease who do not have residual ischemia and have an ejection fraction above 35%. This trial aims to determine if flecainide is superior to amiodarone in successfully restoring normal heart rhythm and whether its safety is comparable. The study also seeks to assess if flecainide reduces hospital admissions, shortens the time to cardioversion, and decreases the need for electrical cardioversion. Participants will be randomly assigned to receive either intravenous flecainide or amiodarone in the Emergency Department. Flecainide is given as 2.0 mg/kg over 10 minutes, while amiodarone is administered at 5.0-7.0 mg/kg over 1 hour, followed by a maintenance dose for up to 24 hours. All patients will be monitored continuously with ECG for six hours after treatment starts, and a 24-hour Holter monitor will be placed. Patients stay in the Emergency Department for six hours post-treatment and are discharged if no adverse events occur; otherwise, hospitalization is required. During the study, patients will have follow-up visits 24 hours after treatment for physical exams, ECG, cardiac ultrasound, and removal of the Holter monitor, with evaluation of any adverse effects. At 30 days, a phone call follow-up will be conducted to review outcomes and any side effects. The primary outcomes include the rate of successful cardioversion within six hours and the presence of specific heart rhythm abnormalities or low blood pressure. Secondary outcomes include discharge rates in normal rhythm, cardioversion success over 24 hours, time to cardioversion, frequency of electrical cardioversion, arrhythmia burden, and adverse events over 30 days.
CONDITIONS
Brief Title
Flecainide Versus Amiodarone in the Cardioversion of Paroxysmal Atrial Fibrillation at the Emergency Department, in Patients With Coronary Artery Disease Without Residual Ischemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 85 years
- Paroxysmal atrial fibrillation documented by 12-lead ECG
- Atrial fibrillation onset less than 48 hours from Emergency Department presentation, or onset between 48 hours and 7 days with at least 30 days of anticoagulation
- History of coronary artery disease without residual ischemia, defined by recent PCI or CABG or negative stress testing within 1 year with specific criteria
- Ejection fraction greater than 35% documented by cardiac ultrasound within 1 year or at Emergency Department
- Signed informed consent from patient or legal representative
You will not qualify if you...
- Atrial flutter on ECG at Emergency Department
- Newly diagnosed left or right bundle branch block with QRS duration over 150ms
- More than 720 premature ventricular contractions or non-sustained ventricular tachycardia on previous 24-hour ECG monitoring
- No history of coronary artery disease
- Recent myocardial infarction (STEMI or NSTEMI) based on troponin levels
- Unstable angina or myocardial ischemia at rest or minimal effort
- Known residual ischemia based on stress testing or history
- Acute coronary syndrome within 1 year
- Severe aortic valve stenosis
- Severe chronic kidney disease stage 4 or higher
- Severe systemic diseases including active cancer treatment, liver failure, or infection with fever
- Use of flecainide or propafenone within 6 hours before Emergency Department visit
- Known allergy or intolerance to flecainide or amiodarone
- Pregnancy or breastfeeding
- Participation in other clinical trials
- Life expectancy less than 1 year
- Unable or unwilling to follow study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 hours
Participants receive intravenous Flecainide or Amiodarone for cardioversion of paroxysmal atrial fibrillation at the Emergency Department.
1 treatment visit in the Emergency Department
Duration - 30 days
Participants are monitored for arrhythmias, adverse events, and cardioversion success after treatment.
Follow-up assessments during 30 days after treatment
Trial Site Locations
Total: 3 locations
1
First Department of Cardiology, Hippocration General Hospital, National and Kapodistrian University of Athens, Athens, Greece
Athens, Greece, 11527
Actively Recruiting
2
Konstantopoulio General Hospital
Athens, Greece, 14233
Actively Recruiting
3
KAT General Hospital
Athens, Greece, 14561
Actively Recruiting
Research Team
K
Konstantinos P Tsioufis, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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