Catheter Ablation Versus Thoracoscopic Ablation to Patients With Permanent Atrial Fibrillation

Not Applicable

Terminated

• Conditions: Atrial Fibrillation

• Registration Number: NCT00296166
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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.

Detailed 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

Study Timeline

• Study First Submitted: 2006-02-23
• Study First Submitted QC: 2006-02-23
• Study First Posted: 2006-02-24
• Study Start: 2006-11
• Status Verified: 2007-07
• Last Update Submitted: 2010-09-01
• Last Update Posted: 2010-09-02
• Study Completion: 2010-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Presence of sinus rhythm	after 6 months from treatment

Secondary Outcome Measures

Name	Time	Method
complications	during 12 months from treatment
cost-effectiveness	during 12 months from treatment
structural changes (evaluated by echocardiography)	during 12 months from treatment
p-BNP	during 12 months from treatment
inflammatory markers	during 12 months from treatment
atrial fibrillation burden evaluated by Holter monitoring	at 6 months from treatment
exercise performance	at 3 months from treatment
Quality of life	at 3 months from treatment

Trial Locations

Locations (1)

Risghospitalet,; 🇩🇰 Copenhagen, Denmark