Comparison of Two Strategies for the Management of Atrial Fibrillation After Cardiac Surgery (FAAC)

Caen University Hospital

Status and phase: Unknown; Phase 4

Conditions: Cardiac Surgery; Atrial Fibrillation

Treatments: Drug: Landiolol; Drug: Amiodarone

Study type: Interventional

Funder types: Other

Identifiers

NCT04223739

2019-A00763-54

Details and patient eligibility

About

Postoperative atrial fibrillation is a common complication after cardiac surgery with a rate of 30%. However, management of postoperative atrial fibrillation is controversial. Two strategies are recommended : heart rate control using a betablocker or rhythm control with amiodarone.

Landiolol is a new-generation beta-blocker with a short half-life, which was approved by the Haute Autorité de Santé to be used in perioperative supra-ventricular tachycardias.

Only one study compared landiolol to amiodarone in the perioperative setting, with a better hemodynamic tolerance and a higher rate of conversion to sinus rhythm with landiolol. However this was a single-center and retrospective study.

The aim of our multicenter randomized study is to compare the effectiveness of landiolol in reducing atrial fibrillation to sinus rhythm compared to amiodarone in the postoperative period after cardiac surgery.

Full description

Randomized clinical study comparing landiolol and amiodarone for treatment of atrial fibrillation following cardiac surgery

Enrollment: 380 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients hospitalized in the cardiac ICU after having undergone cardiac surgery (CABG, aortic valve or ascending aortic root replacement or a combination of both)
• New onset of atrial fibrillation lasting more than 30 minutes in the postoperative period after cardiac surgery
• French speaking patients
• Written consent
• Patients with social security insurance

Exclusion criteria

• Hemodynamic instability requiring electrical cardioversion of atrial fibrillation
• Sepsis
• Bradyarrythmia (< 90/min)
• Patients requiring inotropes in the postoperative period
• Patient with pre-existing atrial fibrillation
• Patient with anticoagulant therapy before surgery
• Contraindication to amiodarone or beta-blockers
• Urgent surgery (< 24h), ventricular assist device, heart transplant, TAVR, mechanical valve, mitral or tricuspid valve replacement.
• No written consent
• Pregnant women,
• Underaged patients (<18 years old)
• Patients not able to give consent (curators, patients deprived of public rights)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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380 participants in 2 patient groups

Landiolol

Active Comparator group

Description:

Landiolol infusion starting at 2.5 µg/kg/min and titrating up to 80µg/kg/min with a heart rate goal of under 90 bpm.

Treatment:

Drug: Landiolol

Amiodarone

Active Comparator group

Description:

Amiodarone bolus of 5-7 mg/kg in 1 hour, followed by an infusion of 1g/day until conversion to sinus rhythm.

Treatment:

Drug: Amiodarone