Clinical trial NCT00296166: 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
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Permanent Atrial fibrillation
catheter ablation
thoracoscopy
Arrhythmia
Heart
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2006-02-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Presence of sinus rhythm
timeFrame: after 6 months from treatment
Secondary outcomes:
measure: complications
timeFrame: during 12 months from treatment
measure: cost-effectiveness
timeFrame: during 12 months from treatment
measure: structural changes (evaluated by echocardiography)
timeFrame: during 12 months from treatment
measure: p-BNP
timeFrame: during 12 months from treatment
measure: inflammatory markers
timeFrame: during 12 months from treatment
measure: atrial fibrillation burden evaluated by Holter monitoring
timeFrame: at 6 months from treatment
measure: exercise performance
timeFrame: at 3 months from treatment
measure: Quality of life
timeFrame: at 3 months from treatment
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Risghospitalet,
Study officials:
affiliation: Rigshospitalet, Denmark
name: Jesper H Svendsen, MD
role: PRINCIPAL_INVESTIGATOR
References: