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Clinical Trials/NCT01360918
NCT01360918
Terminated
Not Applicable

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

Medisch Spectrum Twente1 site in 1 country2 target enrollmentMay 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
Medisch Spectrum Twente
Enrollment
2
Locations
1
Primary Endpoint
Recurrence of atrial fibrillation
Status
Terminated
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2011
End Date
May 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

B. Oude Velthuis

B. Oude Velthuis MD.

Medisch Spectrum Twente

Eligibility Criteria

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

Outcomes

Primary Outcomes

Recurrence of atrial fibrillation

Time Frame: 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 Outcomes

  • Duration of hospitalization(One year)

Study Sites (1)

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