Clinical trial NCT04223739: Comparison of Two Strategies for the Management of Atrial Fibrillation After Cardiac Surgery
Official title: Comparison of Two Strategies for the Management of Atrial Fibrillation After Cardiac Surgery : a Randomized Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atrial Fibrillation
Cardiac Surgery
Keywords: Cardiac Surgery
Atrial Fibrillation
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of patients in sinus rhythm 48 hours after the onset of atrial fibrillation immediate postoperative period after cardiac surgery
timeFrame: Day 2 after onset of atrial fibrillation
Secondary outcomes:
measure: Haemodynamic side effects (hypotension, bradycardia)
timeFrame: Day 8 after onset of atrial fibrillation and through hospital discharge, an average of 14 days
measure: Length of hospital stay
timeFrame: Day 8 after onset of atrial fibrillation and through hospital discharge, an average of 14 days
measure: Rate of thrombo-embolic events
timeFrame: 2 months postsugery and 1 year postsurgery
measure: Quality of life evaluated by the EQ 5D 3L questionnaire
timeFrame: 2 months postsurgery and 1 year postsurgery
measure: Rate of atrial fibrillation recurrence
timeFrame: 2 months postsurgery and 1 year postsurgery
measure: Severe hemorrhagic complications due to anticoagulant therapy, as defined by the Haute Autorité de Santé
timeFrame: 2 months postsurgery and 1 year postsurgery
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
state: Calvados
Study officials:
affiliation: University Hospital, Caen
name: Edouard Caspersen, MD
role: PRINCIPAL_INVESTIGATOR
References: