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

Primary Purpose

Atrial Fibrillation, Cardiac Surgery

Status

Unknown status

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Landiolol

Amiodarone

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Cardiac Surgery, Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Caen University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Landiolol

Amiodarone

Arm 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.

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

Outcomes

Primary Outcome Measures

Percentage of patients in sinus rhythm 48 hours after the onset of atrial fibrillation immediate postoperative period after cardiac surgery

Secondary Outcome Measures

Haemodynamic side effects (hypotension, bradycardia)

Length of hospital stay

Length of stay in the hospital from randomisation to hospital discharge

Rate of thrombo-embolic events

Rate of stroke or ischemic embolism

Quality of life evaluated by the EQ 5D 3L questionnaire

Quality of life as evaluated by the EQ 5D 3L questionnaire

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

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

Full Information

NCT ID

NCT04223739

First Posted

December 13, 2019

Last Updated

January 8, 2020

Sponsor

University Hospital, Caen

1. Study Identification

Unique Protocol Identification Number

NCT04223739

Brief Title

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

Acronym

FAAC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 13, 2019 (Actual)

Primary Completion Date

June 1, 2021 (Anticipated)

Study Completion Date

June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Caen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Cardiac Surgery

Keywords

Cardiac Surgery, Atrial Fibrillation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

380 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Landiolol

Arm Type

Active Comparator

Arm 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.

Arm Title

Amiodarone

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Landiolol

Other Intervention Name(s)

Rapibloc

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Amiodarone

Other Intervention Name(s)

Cordarone

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of patients in sinus rhythm 48 hours after the onset of atrial fibrillation immediate postoperative period after cardiac surgery

Description

Percentage of patients in sinus rhythm 48 hours after the onset of atrial fibrillation immediate postoperative period after cardiac surgery

Time Frame

Day 2 after onset of atrial fibrillation

Secondary Outcome Measure Information:

Title

Haemodynamic side effects (hypotension, bradycardia)

Description

Haemodynamic side effects (hypotension, bradycardia)

Time Frame

Day 8 after onset of atrial fibrillation and through hospital discharge, an average of 14 days

Title

Length of hospital stay

Description

Length of stay in the hospital from randomisation to hospital discharge

Time Frame

Day 8 after onset of atrial fibrillation and through hospital discharge, an average of 14 days

Title

Rate of thrombo-embolic events

Description

Rate of stroke or ischemic embolism

Time Frame

2 months postsugery and 1 year postsurgery

Title

Quality of life evaluated by the EQ 5D 3L questionnaire

Description

Quality of life as evaluated by the EQ 5D 3L questionnaire

Time Frame

2 months postsurgery and 1 year postsurgery

Title

Rate of atrial fibrillation recurrence

Description

Percentage of patients having a recurrence of atrial fibrillation after the initial conversion to sinus rythm in the postoperative period

Time Frame

2 months postsurgery and 1 year postsurgery

Title

Severe hemorrhagic complications due to anticoagulant therapy, as defined by the Haute Autorité de Santé

Description

Time Frame

2 months postsurgery and 1 year postsurgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Edouard Caspersen, MD

Phone

+33 02 31 06 47 36

caspersen-e@chu-caen.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Marc-Olivier Fischer, MD-PhD

Phone

+33 02 31 06 47 36

fischer-mo@chu-caen.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edouard Caspersen, MD

Organizational Affiliation

University Hospital, Caen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Caen University Hospital

City

Caen

State/Province

Calvados

ZIP/Postal Code

14000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Edouard Caspersen, MD

Phone

+33 02 31 06 47 36

caspersen-e@chu-caen.fr

First Name & Middle Initial & Last Name & Degree

Edouard Caspersen, MD

First Name & Middle Initial & Last Name & Degree

Marc-Olivier Fischer, MD PhD

12. IPD Sharing Statement

Learn more about this trial

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

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