Concomitant Epicardial Pulmonary Vein Isolation in Patients With Atrial Fibrillation Undergoing Elective Cardiac Surgery

Study Overview
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Brief Summary
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Recent studies demonstrated that radiofrequency isolation of the pulmonary veins (PVI) is a superior alternative to antiarrhythmic drug therapy in patients with symptomatical paroxysmal atrial fibrillation (AF). A substantial proportion of patients undergoing elective cardiac surgery also suffer from atrial fibrillation. No evidence exists if epicardial PVI is beneficial in patients with a history of AF undergoing coronary bypass surgery (CABG) for the concomitant treatment of AF. The investigators aim to establish the effectiveness of incorporating epicardial pulmonary vein isolation into elective cardiac surgery.

Official Title
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Concomitant Epicardial Pulmonary Vein Isolation in Patients With Atrial Fibrillation Undergoing Elective Cardiac Surgery

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Epicardial pulmonary vein isolation
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 18 years of age EHRA class ≤ 2 Documented history of paroxysmal, persistent, longstanding persistent or newly-diagnosed AF prior to admittance for cardiac surgery Patients will have elective coronary surgery planned Able of providing informed consent Exclusion Criteria: Patients ≥70 years of age Pregnancy Patients with contraindications for oral anticoagulant agents Patients undergoing emergency operation Patients undergoing concomitant valve replacement Severely enlarged LA (>50 mm) on echocardiography Prior AF ablation or AF surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care<br> | Other: Usual care<br>* Management of atrial fibrillation according to current guidelines using rate control pharmacological therapy.<br>|
| Active Comparator: Pulmonary vein isolation<br> | Device: Epicardial pulmonary vein isolation<br>* After the CABG procedure, a bilateral epicardial pulmonary vein isolation is performed under general anaesthesia and double-lumen endotracheal ventilation.<br>* Other names: Medtronic Cardioblate BP2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of atrial fibrillation | The percentage of patients without a recurrence of AF, without antiarrhythmic drugs (AADs), within a follow-up period of at least 12 months after a stabilisation period of 90 days after the initial procedure. An episode of AF is defined as an episode of at least 30 seconds duration. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospitalization | Secondary objectives include the duration of hospitalization | One year |