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

Atrial Fibrillation Clinical Trial

— CONTROL-AF  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01360918
• Other study ID #: NL35192.044.11
• Status: Terminated
• Phase: N/A
• First received: May 13, 2011
• Last updated: July 6, 2016
• Start date: May 2011
• Est. completion date: May 2014

Study information

• Verified date: July 2016
• Source: Medisch Spectrum Twente
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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:
• Usual care
Management of atrial fibrillation according to current guidelines using rate control pharmacological therapy.

Locations

Country	Name	City	State
Netherlands	Medisch Spectrum Twente	Enschede	Overijssel

Sponsors (2)

Lead Sponsor	Collaborator
Medisch Spectrum Twente	Cardio Research Enschede BV

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one year	No
Secondary	Duration of hospitalization	Secondary objectives include the duration of hospitalization	One year	No