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

NCT ID: NCT06142604

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-12-31

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.

Conditions

Atrial Fibrillation; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Flecainide

Intervention Type: DRUG

Single 300mg dose of oral flecainide

No flecainide

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Flecainide

Single 300mg dose of oral flecainide

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Population Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2023-FLIPAF

Identifier Type: -

Identifier Source: org_study_id