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

NCT06142604 | Withdrawn Phase 4

• 1 other identifier: 2023-FLIPAF
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation; Surgery

Keywords

Flecainide

Outcome Measures

Primary Outcomes (2)

• Recruitment rate

  Minimum recruitment rate of at least 1.5 patients per site per month

  through study completion, an average of six months

• Follow-up completion rate

  Completion rate of at least 90%

  through study completion, an average of six months

Study Arms (2)

Flecainide

EXPERIMENTAL

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.

Drug: Flecainide

No flecainide

NO INTERVENTION

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.

Interventions

Flecainide DRUG

Single 300mg dose of oral flecainide

Flecainide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• known left ventricular ejection fraction ≤ 40%;
• myocardial infarction within the last 30 days;
• QRS interval \>140ms;
• allergy to flecainide;
• severe uncorrected hypokalemia (\<2.5 mEq/L) or hyperkalemia (\>6.5 mEq/L) at the time of randomization;
• severe acute liver dysfunction or history of advanced cirrhosis;
• severe renal insufficiency (eGFR ≤ 30ml/min or dialysis); OR,
• 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.

Sponsors & Collaborators

• Population Health Research Institute: lead

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Flecainide

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 21, 2023
• Study Start: July 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: August 29, 2024

Record last verified: 2024-08