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

  • STATUS
    Recruiting
  • End date
    Jun 1, 2022
  • participants needed
    380
  • sponsor
    University Hospital, Caen
Updated on 23 January 2021
heart surgery
coronary artery bypass graft
amiodarone
beta-adrenergic blocking agents

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 Autorit de Sant 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.

Description

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

Details
Condition Thoracic Surgery, Arrhythmia, Atrial Fibrillation, heart surgery, Atrial Fibrillation (Pediatric), Cardiac Surgery, Dysrhythmia, cardiac operation
Treatment Amiodarone, Landiolol
Clinical Study IdentifierNCT04223739
SponsorUniversity Hospital, Caen
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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)
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