Concomitant Epicardial Pulmonary Vein Isolation in Patients With Atrial Fibrillation Undergoing Elective Cardiac Surgery (CONTROL-AF)

Medisch Spectrum Twente

Status: Terminated

Conditions: Atrial Fibrillation

Treatments: Other: Usual care; Device: Epicardial pulmonary vein isolation

Study type: Interventional

Funder types: Other

Identifiers

NCT01360918

NL35192.044.11

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Usual care

Active Comparator group

Treatment:

Other: Usual care

Pulmonary vein isolation

Active Comparator group

Treatment:

Device: Epicardial pulmonary vein isolation