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NCT06142604 | WITHDRAWN | Atrial Fibrillation

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

Condition or disease

Atrial Fibrillation

Surgery

Intervention/treatment

Flecainide

Phase

PHASE4

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 Type : INTERVENTIONAL
Estimated Enrollment : 0 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Single Dose Flecainide for Early Sinus Rhythm Conversion of Perioperative Atrial Fibrillation After Noncardiac Surgery (FLIP-AF): a Pilot Randomized Controlled Trial
Actual Study Start Date : 2024-07-01
Estimated Primary Completion Date : 2025-06-30
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Single Dose Flecainide for Early Sinus Rhythm Conversion of Perioperative Atrial Fibrillation After Noncardiac Surgery

Location Details

NCT06142604

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