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Concomitant epicardial pulmonary vein isolation in patients with atrial fibrillation undergoing elective cardiac surgery

Completed
Conditions
atrial fibrillation
10007521
Registration Number
NL-OMON36466
Lead Sponsor
Medisch Spectrum Twente
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
70
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
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The percentage of patients without a recurrence of AF, without AADs, within a<br /><br>follow-up period of at least 12 months after a stabilisation period of 90 days<br /><br>after the initial procedure. An episode of AF is defined as an episode of at<br /><br>least 30 seconds duration.<br /><br><br /><br>The percentage of patients without post-operative atrial fibrillation during<br /><br>admission. An episode of AF is defined as an episode of at least 30 seconds<br /><br>duration.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary outcomes include comparison of cost and duration of hospitalization,<br /><br>post-procedural discomfort and experienced AF burden during follow-up.</p><br>
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