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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01360918

Acronym

CONTROL-AF

Enrollment

Registered

2011-05-26

Start date

2011-05-31

Completion date

2014-05-31

Last updated

2016-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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.

Interventions

DEVICEEpicardial pulmonary vein isolation

After the CABG procedure, a bilateral epicardial pulmonary vein isolation is performed under general anaesthesia and double-lumen endotracheal ventilation.

OTHERUsual care

Management of atrial fibrillation according to current guidelines using rate control pharmacological therapy.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Duration of hospitalization	One year	Secondary objectives include the duration of hospitalization

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026