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

Not Applicable

Terminated

• Conditions: Atrial Fibrillation
• Interventions: Other: Usual care; Device: Epicardial pulmonary vein isolation

• Registration Number: NCT01360918
• Lead Sponsor: Medisch Spectrum Twente

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-13
• Study First Submitted QC: 2011-05-25
• Study First Posted: 2011-05-26
• Primary Completion: 2013-05
• Study Completion: 2014-05
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-06
• Last Update Posted: 2016-07-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Usual care	Usual care	-
Pulmonary vein isolation	Epicardial pulmonary vein isolation	-

Primary Outcome Measures

Name	Time	Method
Recurrence of atrial fibrillation	one year	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.

Secondary Outcome Measures

Name	Time	Method
Duration of hospitalization	One year	Secondary objectives include the duration of hospitalization

Trial Locations

Locations (1)

Medisch Spectrum Twente; 🇳🇱 Enschede, Overijssel, Netherlands