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

This study is currently recruiting participants.
Verified April 2012 by Medisch Spectrum Twente
Sponsor:
Collaborator:
Cardio Research Enschede BV
Information provided by (Responsible Party):
B. Oude Velthuis, Medisch Spectrum Twente
ClinicalTrials.gov Identifier:
NCT01360918
First received: May 13, 2011
Last updated: April 20, 2012
Last verified: April 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360918

Contacts
Contact: Bob Oude Velthuis, MD MSc +31534872110 b.oudevelthuis@mst.nl
Contact: Harald Verheij +31534872105 h.verheij@mst.nl

Locations
Netherlands
Medisch Spectrum Twente Recruiting
Enschede, Overijssel, Netherlands
Contact: Harald Verheij     +31534872105     h.verheij@mst.nl    
Contact: Bob Oude Velthuis, MSc MD     +31534872110     b.oudevelthuis@mst.nl    
Sponsors and Collaborators
Medisch Spectrum Twente
Cardio Research Enschede BV
Investigators
Principal Investigator: Marcoen Scholten, MD PhD Medisch Spectrum Twente
  More Information

No publications provided

Responsible Party: B. Oude Velthuis, B. Oude Velthuis MD., Medisch Spectrum Twente
ClinicalTrials.gov 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
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013