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

Sponsor
Medisch Spectrum Twente (Other)
Overall Status
Terminated
CT.gov ID
NCT01360918
Collaborator
Foundation of Cardiovascular Research and Education Enschede (Other)
2
Enrollment
1
Location
2
Arms
36
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Epicardial pulmonary vein isolation
  • Other: Usual care
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Concomitant Epicardial Pulmonary Vein Isolation in Patients With Atrial Fibrillation Undergoing Elective Cardiac Surgery
Study Start Date :
May 1, 2011
Actual Primary Completion Date :
May 1, 2013
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Medtronic Cardioblate BP2

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Duration of hospitalization [One year]

      Secondary objectives include the duration of hospitalization

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 Medisch Spectrum Twente Enschede Overijssel Netherlands

    Sponsors and Collaborators

    • Medisch Spectrum Twente
    • Foundation of Cardiovascular Research and Education Enschede

    Investigators

    • Principal Investigator: Marcoen Scholten, MD PhD, Medisch Spectrum Twente

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    B. Oude Velthuis, B. Oude Velthuis MD., Medisch Spectrum Twente
    ClinicalTrials.gov Identifier:
    NCT01360918
    Other Study ID Numbers:
    • NL35192.044.11
    First Posted:
    May 26, 2011
    Last Update Posted:
    Jul 7, 2016
    Last Verified:
    Jul 1, 2016
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of Jul 7, 2016