Totally Endoscopic Ablation of Atrial Fibrillation

Study Overview
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Brief Summary
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Primary Objective To evaluate the efficiency of totally endoscopic ablation of AF compared to rate control management of AF. Secondary Objectives Does totally endoscopic ablation: reduce atrial fibrillation symptoms? increase working capacity and improve quality of life? improve atrial function? reduce the risk for stroke?

Detailed Description
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This is a randomized open controlled single centre study that involves 60 patients (men and women) over the age of 50 years with longstanding persistent AF of more than one year duration and in the absence of other severe cardiopulmonary disease. One of the participating investigators informs the patient, both verbally and in writing, about the study and what participation in the study involves. The patient will be given time to ask questions and to consider study participation and can be enrolled in the study after signing and dating written Informed Consent. Study duration per patient is 12 months. After inclusion, the patient will be divided into one of two groups, treatment group or control group, according to block wise randomization. The patient will be asked to complete two health related questionnaires SF 36 and SCL and a transthoracic echocardiography will be conducted together with an exercise test. The patients will thereafter be assessed according to randomisation. Irrespective of group, the patients will be rescheduled for a visit within two months for totally endoscopic ablation and Reveal implantation or just Reveal implantation (control group). All patients will then be assessed during follow-ups after 1, 3, 6 and 12 months.

Official Title
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Totally Endoscopic Ablation of Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Endoscopic ablation of AF
* Drug: Rate control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 50 years Longstanding persistent AF of > 1 year duration Severe symptoms related to AF Have signed and dated Informed Consent. Willing and able to comply with the protocol for the duration of the trial. Exclusion Criteria: Severe ischemic heart disease or heart valve disease Thrombus formation in left atrial appendage Intolerance to warfarin medication Advanced pulmonary disease, FEV 1 < 1.5 litre Left atrial diameter > 60 mm Body Mass Index (BMI) > 35 kg/m2 Previous pulmonary or heart surgery Participation in another clinical trial within the last 30 days prior to enrollment

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic ablation of atrial fibrillation<br> | Procedure: Endoscopic ablation of AF<br>* The procedure is conducted in general anaesthesia. The right chest is entered with three working ports . After a complete cycle of ablation creating a box lesion in the left atrium, conduction block is tested. A chest tube is placed through the most caudal port and the port incisions are closed. A Reveal loop recorder is then implanted subcutaneously. The patient is extubated and transferred to postoperative care.<br>|
| Active Comparator: Rate control<br> | Drug: Rate control<br>* Anti-arrhythmic protocol The control group is using a rate-control strategy. All patients keep their anti-arrhythmic/beta-blocker/digoxin medication during the entire follow-up. No attempts are made to rhythm-control the patients, unless subjective symptoms make it necessary.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom of AF 3 - 12 months postoperatively without antiarrhythmic drugs |  | 3-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom of symptomatic AF episodes 3 - 12 months |  | 3-12 months | 
| Exercise capacity after 12 months |  | 12 months | 
| Quality-of-life assessment (SF-36 and SCL) 3, 6 and 12 months |  | 12 months | 
| Atrial function and dimensions after 6 and 12 months |  | 12 months | 
| Freedom of thromboembolic events during the study |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Ablation, Thoracoscopy, Atrial function