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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Medisch Spectrum Twente.
Recruitment status was  Recruiting
Cardio Research Enschede BV
Information provided by (Responsible Party):
B. Oude Velthuis, Medisch Spectrum Twente Identifier:
First received: May 13, 2011
Last updated: April 20, 2012
Last verified: April 2012
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.

Condition Intervention
Atrial Fibrillation
Device: Epicardial pulmonary vein isolation
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Concomitant Epicardial Pulmonary Vein Isolation in Patients With Atrial Fibrillation Undergoing Elective Cardiac Surgery

Resource links provided by NLM:

Further study details as provided by Medisch Spectrum Twente:

Primary Outcome Measures:
  • Recurrence of atrial fibrillation [ Time Frame: one year ] [ Designated as safety issue: No ]
    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:
  • Duration of hospitalization [ Time Frame: One year ] [ Designated as safety issue: No ]
    Secondary objectives include the duration of hospitalization

Estimated Enrollment: 70
Study Start Date: May 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Usual care Other: Usual care
Management of atrial fibrillation according to current guidelines using rate control pharmacological therapy.
Active Comparator: Pulmonary vein isolation Device: Epicardial pulmonary vein isolation
After the CABG procedure, a bilateral epicardial pulmonary vein isolation is performed under general anaesthesia and double-lumen endotracheal ventilation.
Other Name: Medtronic Cardioblate BP2


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01360918

Contact: Bob Oude Velthuis, MD MSc +31534872110
Contact: Harald Verheij +31534872105

Medisch Spectrum Twente Recruiting
Enschede, Overijssel, Netherlands
Contact: Harald Verheij    +31534872105   
Contact: Bob Oude Velthuis, MSc MD    +31534872110   
Sponsors and Collaborators
Medisch Spectrum Twente
Cardio Research Enschede BV
Principal Investigator: Marcoen Scholten, MD PhD Medisch Spectrum Twente
  More Information

Responsible Party: B. Oude Velthuis, B. Oude Velthuis MD., Medisch Spectrum Twente Identifier: NCT01360918     History of Changes
Other Study ID Numbers: NL35192.044.11 
Study First Received: May 13, 2011
Last Updated: April 20, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes processed this record on May 23, 2016