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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-05-31

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.

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual care

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

Management of atrial fibrillation according to current guidelines using rate control pharmacological therapy.

Pulmonary vein isolation

Group Type ACTIVE_COMPARATOR

Epicardial pulmonary vein isolation

Intervention Type DEVICE

After the CABG procedure, a bilateral epicardial pulmonary vein isolation is performed under general anaesthesia and double-lumen endotracheal ventilation.

Interventions

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Epicardial pulmonary vein isolation

After the CABG procedure, a bilateral epicardial pulmonary vein isolation is performed under general anaesthesia and double-lumen endotracheal ventilation.

Intervention Type DEVICE

Usual care

Management of atrial fibrillation according to current guidelines using rate control pharmacological therapy.

Intervention Type OTHER

Other Intervention Names

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Medtronic Cardioblate BP2

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No