Catheter Ablation Versus Thoracoscopic Ablation to Patients With Permanent Atrial Fibrillation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2010-11-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Catheter ablation

Intervention Type PROCEDURE

Thoracoscopic epicardial ablation

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No