Catheter Ablation Versus Thoracoscopic Ablation to Patients With Permanent Atrial Fibrillation

Rigshospitalet

Status

Terminated

Conditions

Atrial Fibrillation

Treatments

Procedure: Thoracoscopic epicardial ablation

Procedure: Catheter ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT00296166

KAT-SKOPI study

KF - 01-284215

Details and patient eligibility

About

Patents with atrial fibrillation can be treated with the purpose of curing the arrhythmia.This may be achieved by catheter ablation and Maze surgery where the latter includes open heart surgery.

By catheter ablation the arrhythmia can be cured in about 70 % of patients who have episodes of atrial fibrillation. In patients with permanent atrial fibrillation the results are not as good.

We will compare a conventional ablation approach where lesions are created on the inside of the heart with a thoracoscopic approach where the lesions are created from the outside of the heart.

Full description

Patients with permanent atrial fibrillation will be considered for randomisation Patients will be randomised to either conventional endocardial catheter ablation or epicardial thoracoscopic ablation.

Objectives of study:

Primary endpoint:presence of sinus rhythm after 6 months Secondary endpoints: complications, cost-effectiveness, structural changes (evaluated by echocardiography), p-BNP and inflammatory markers, atrial fibrillation burden evaluated by Holter monitoring

Enrollment

200 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Permanent atrial fibrillation documented on at least 2 ecg´s with more than 1 month between ecg´s. The diagnosis is verified on Holter.
All patients have symptoms or do not tolerate rate control treatment.

Exclusion criteria

Psychiatric disease or suspicion of incapability to give informed concent
Females with birth giving potential
Previous heart surgery
Previous ablation for atrial fibrillation
Life expectance less than 1 year
Congenital heart disease
Expected need for heart surgery
Heart failure (NYHA class IV)
Inability to be treated with anticoagulation
In case of previous deep venous thromboembolism og stroke the investigators will individually consider if the patient is suitable for inclusion.