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

Phase 4

Withdrawn

• Conditions: Atrial Fibrillation; Surgery
• Interventions: Drug: Flecainide

• Registration Number: NCT06142604
• Lead Sponsor: Population Health Research Institute

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.

Study Timeline

• Study First Submitted: 2023-11-10
• Study First Submitted QC: 2023-11-16
• Study First Posted: 2023-11-21
• Study Start: 2024-07-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-29
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flecainide	Flecainide	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.

Primary Outcome Measures

Name	Time	Method
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%