Status:
WITHDRAWN
Single Dose Flecainide for Early Sinus Rhythm Conversion of Perioperative Atrial Fibrillation After Noncardiac Surgery
Lead Sponsor:
Population Health Research Institute
Conditions:
Atrial Fibrillation
Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Investigator-initiated pilot study of single dose oral flecainide versus no flecainide for the early conversion of perioperative atrial fibrillation to sinus rhythm after noncardiac surgery.
Detailed Description
FLIP-AF is a prospective, randomized, open-label trial of single dose flecainide versus no flecainide in patients with perioperative atrial fibrillation after noncardiac surgery. The primary objective...
Eligibility Criteria
Inclusion
- Age ≥ 18 years;
- Noncardiac surgery in the last 30 days requiring an overnight hospital admission;
- Presence of AF (i.e., atrial fibrillation and/or flutter) with a ventricular heart rate of ≥ 100 beats per minute at any time within 12 hours prior to randomization;
- In AF at the time of randomization; AND,
- Provided written informed consent.
Exclusion
- History of AF without normal sinus rhythm documented within 90 days prior to randomization;
- Hemodynamic instability;
- Have any one of the following contraindications to flecainide:
- known left ventricular ejection fraction ≤ 40%;
- myocardial infarction within the last 30 days;
- QRS interval \>140ms;
- allergy to flecainide;
- severe uncorrected hypokalemia (\<2.5 mEq/L) or hyperkalemia (\>6.5 mEq/L) at the time of randomization;
- severe acute liver dysfunction or history of advanced cirrhosis;
- severe renal insufficiency (eGFR ≤ 30ml/min or dialysis); OR,
- second or third degree atrioventricular block within the last 30 days, in the absence of a pacemaker device;
- Unable to take oral medication;
- Previously enrolled in the trial.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06142604
Start Date
July 1 2024
End Date
December 31 2025
Last Update
August 29 2024
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