Single Dose Flecainide for Early Sinus Rhythm Conversion of Perioperative Atrial Fibrillation After Noncardiac Surgery

Single Dose Flecainide for Early Sinus Rhythm Conversion of Perioperative Atrial Fibrillation After Noncardiac Surgery (FLIP-AF): a Pilot Randomized Controlled Trial

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06142604

Acronym

FLIP-AF

Enrollment

Registered

2023-11-21

Start date

2024-07-01

Completion date

2025-12-31

Last updated

2024-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Surgery

Keywords

Flecainide

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 is to determine whether it is feasible to conduct a large randomized controlled trial assessing the efficacy and safety of single dose flecainide in this population.

Interventions

DRUGFlecainide

Single 300mg dose of oral flecainide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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 criteria

* 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: 1. known left ventricular ejection fraction ≤ 40%; 2. myocardial infarction within the last 30 days; 3. QRS interval \>140ms; 4. allergy to flecainide; 5. severe uncorrected hypokalemia (\<2.5 mEq/L) or hyperkalemia (\>6.5 mEq/L) at the time of randomization; 6. severe acute liver dysfunction or history of advanced cirrhosis; 7. severe renal insufficiency (eGFR ≤ 30ml/min or dialysis); OR, 8. 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.

Design outcomes

Primary

Measure	Time frame	Description
Recruitment rate	through study completion, an average of six months	Minimum recruitment rate of at least 1.5 patients per site per month
Follow-up completion rate	through study completion, an average of six months	Completion rate of at least 90%

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026