Single Dose Flecainide for Early Sinus Rhythm Conversion of Perioperative Atrial Fibrillation After Noncardiac Surgery (FLIP-AF)

Population Health Research Institute (PHRI)

Status and phase: Withdrawn; Phase 4

Conditions: Atrial Fibrillation; Surgery

Treatments: Drug: Flecainide

Study type: Interventional

Funder types: Other

Identifiers

NCT06142604

2023-FLIPAF

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

0 participants in 2 patient groups

Flecainide

Experimental group

Description:

Participants randomized to the flecainide arm will be prescribed a single 300mg dose of oral flecainide, to be given as soon as possible after study randomization. Rate controlling drugs will be prescribed and titrated to achieve a heart rate of less than 100 beats per minute and symptom minimization.

Treatment:

Drug: Flecainide

No flecainide

No Intervention group

Description:

Participants randomized to the no flecainide arm will not be prescribed flecainide. Rate controlling drugs will be prescribed and titrated to achieve a heart rate of less than 100 beats per minute and symptom minimization.