Catheter Ablation Versus Thoracoscopic Ablation to Patients With Permanent Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

A Randomized Study That Will Show the Effects of Catheter Ablation Compared to the Effects of Thoracoscopic Ablation to Patients With Permanent Atrial Fibrillation.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00296166
• Other study ID #: KAT-SKOPI study
• Secondary ID: KF - 01-284215
• Status: Terminated
• Phase: N/A
• First received: February 23, 2006
• Last updated: September 1, 2010
• Start date: November 2006
• Est. completion date: November 2010

Study information

• Verified date: July 2007
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Catheter ablation

• Thoracoscopic epicardial ablation

Locations

Country	Name	City	State
Denmark	Risghospitalet,	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of sinus rhythm		after 6 months from treatment
Secondary	complications		during 12 months from treatment
Secondary	cost-effectiveness		during 12 months from treatment
Secondary	structural changes (evaluated by echocardiography)		during 12 months from treatment
Secondary	p-BNP		during 12 months from treatment
Secondary	inflammatory markers		during 12 months from treatment
Secondary	atrial fibrillation burden evaluated by Holter monitoring		at 6 months from treatment
Secondary	exercise performance		at 3 months from treatment
Secondary	Quality of life		at 3 months from treatment