NCT04223739

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

Comparison of Two Strategies for the Management of Atrial Fibrillation After Cardiac Surgery : a Randomized Multicenter Clinical Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 380 (estimated)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Atrial Fibrillation
• Cardiac Surgery

Interventions

Type	Name	Description
DRUG	Landiolol	Landiolol infusion with incremental doses (range from 2,5µg/kg/min to 80 µg/kg/min) with go of heart rate \< 90 bpm. Doses are modified every 10 minutes if necessary. Once heart rate goal is obtained, switch to an oral dose of Bisoprolol.
DRUG	Amiodarone	Amiodarone loading dose of 5-7 mg/kg in 1 hour followed by an infusion of 1 g/day until conversion to sinus rhythm. Once sinus rhythm is obtained, switch to an oral dose of 200mg/day

Timeline

• Start date: 2019-12-13
• Primary completion: 2021-06-01
• Completion: 2022-06-01
• First posted: 2020-01-10
• Last updated: 2020-01-10

Locations

1 site across 1 country: France