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

Primary Purpose

Atrial Fibrillation

Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Epicardial pulmonary vein isolation
Usual care
Sponsored by
Medisch Spectrum Twente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medisch Spectrum Twente

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Usual care

Pulmonary vein isolation

Arm Description

Outcomes

Primary Outcome Measures

Recurrence of atrial fibrillation
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
Secondary objectives include the duration of hospitalization

Full Information

First Posted
May 13, 2011
Last Updated
July 6, 2016
Sponsor
Medisch Spectrum Twente
Collaborators
Foundation of Cardiovascular Research and Education Enschede
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1. Study Identification

Unique Protocol Identification Number
NCT01360918
Brief Title
Concomitant Epicardial Pulmonary Vein Isolation in Patients With Atrial Fibrillation Undergoing Elective Cardiac Surgery
Acronym
CONTROL-AF
Official Title
Concomitant Epicardial Pulmonary Vein Isolation in Patients With Atrial Fibrillation Undergoing Elective Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
Inclusion rate insufficiënt
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medisch Spectrum Twente
Collaborators
Foundation of Cardiovascular Research and Education Enschede

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
Active Comparator
Arm Title
Pulmonary vein isolation
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Epicardial pulmonary vein isolation
Other Intervention Name(s)
Medtronic Cardioblate BP2
Intervention Description
After the CABG procedure, a bilateral epicardial pulmonary vein isolation is performed under general anaesthesia and double-lumen endotracheal ventilation.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Management of atrial fibrillation according to current guidelines using rate control pharmacological therapy.
Primary Outcome Measure Information:
Title
Recurrence of atrial fibrillation
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Duration of hospitalization
Description
Secondary objectives include the duration of hospitalization
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcoen Scholten, MD PhD
Organizational Affiliation
Medisch Spectrum Twente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medisch Spectrum Twente
City
Enschede
State/Province
Overijssel
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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