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

Atrial Fibrillation Clinical Trial

— FAAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04223739
• Other study ID #: 2019-A00763-54
• Status: Recruiting
• Phase: Phase 4
• Start date: December 13, 2019
• Est. completion date: June 1, 2022

Study information

• Verified date: January 2020
• Source: University Hospital, Caen
• Contact: Edouard Caspersen, MD
• Phone: +33 02 31 06 47 36
• Email: caspersen-e[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 380
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiac Surgery

Intervention

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.
• 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

Locations

Country	Name	City	State
France	Caen University Hospital	Caen	Calvados

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients in sinus rhythm 48 hours after the onset of atrial fibrillation immediate postoperative period after cardiac surgery	Percentage of patients in sinus rhythm 48 hours after the onset of atrial fibrillation immediate postoperative period after cardiac surgery	Day 2 after onset of atrial fibrillation
Secondary	Haemodynamic side effects (hypotension, bradycardia)	Haemodynamic side effects (hypotension, bradycardia)	Day 8 after onset of atrial fibrillation and through hospital discharge, an average of 14 days
Secondary	Length of hospital stay	Length of stay in the hospital from randomisation to hospital discharge	Day 8 after onset of atrial fibrillation and through hospital discharge, an average of 14 days
Secondary	Rate of thrombo-embolic events	Rate of stroke or ischemic embolism	2 months postsugery and 1 year postsurgery
Secondary	Quality of life evaluated by the EQ 5D 3L questionnaire	Quality of life as evaluated by the EQ 5D 3L questionnaire	2 months postsurgery and 1 year postsurgery
Secondary	Rate of atrial fibrillation recurrence	Percentage of patients having a recurrence of atrial fibrillation after the initial conversion to sinus rythm in the postoperative period	2 months postsurgery and 1 year postsurgery
Secondary	Severe hemorrhagic complications due to anticoagulant therapy, as defined by the Haute Autorité de Santé	Hemorrhagic complications requiring surgery or interventional radiology Hemorrhagic complications responsible of hemodynamic instability (Systolic Arterial Pressure < 90 mmHg, or drop of more than 40 mmHg or Mean Arterial Pressure < 65 mmHg or signs of shock) Life threatening hemorrhagic complications (intracerebral, intramedullar or intraocular hemorrhage, hemothorax, abdominal hemorrhage, deep muscular hemorrhage	2 months postsurgery and 1 year postsurgery