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Catheter Ablation Versus Thoracoscopic Ablation to Patients With Permanent Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status

Terminated

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Catheter ablation

Thoracoscopic epicardial ablation

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Permanent Atrial fibrillation, catheter ablation, thoracoscopy, Arrhythmia, Heart

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Risghospitalet,

Outcomes

Primary Outcome Measures

Presence of sinus rhythm

Secondary Outcome Measures

complications

cost-effectiveness

structural changes (evaluated by echocardiography)

p-BNP

inflammatory markers

atrial fibrillation burden evaluated by Holter monitoring

exercise performance

Quality of life

Full Information

NCT ID

NCT00296166

First Posted

February 23, 2006

Last Updated

September 1, 2010

Sponsor

Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT00296166

Brief Title

Catheter Ablation Versus Thoracoscopic Ablation to Patients With Permanent Atrial Fibrillation

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2007

Overall Recruitment Status

Terminated

Why Stopped

Patients with permanent AF are seldomly symptomatic enough to justify intervention. We decided to stop inclusion due to low recruitment rate.

Study Start Date

November 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

Atrial fibrillation, Permanent Atrial fibrillation, catheter ablation, thoracoscopy, Arrhythmia, Heart

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Catheter ablation

Intervention Type

Procedure

Intervention Name(s)

Thoracoscopic epicardial ablation

Primary Outcome Measure Information:

Title

Presence of sinus rhythm

Time Frame

after 6 months from treatment

Secondary Outcome Measure Information:

Title

complications

Time Frame