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

Atrial Fibrillation Clinical Trial

— FLIP-AF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06142604
• Other study ID #: 2023-FLIPAF
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Surgery

Intervention

Drug:
• Flecainide
Single 300mg dose of oral flecainide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Outcome

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