Medical and Surgical Hybrid Treatment of Atrial Fibrillation.

Study Overview
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Brief Summary
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The objective of the study is to investigate the feasibility of a hybrid procedure removal of the atrial fibrillation. This is a single procedure for both surgical epicardial by minimally invasive route (Thoracoscopy) without even flow controlled and supplemented if necessary by extra corporeal intracavitary route at the same time. This faster procedure combined with complete lesions have a higher success rate and less frequent re-hospitalizations of patients.

Official Title
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Medical and Surgical Hybrid Treatment of Atrial Fibrillation: Epicardial and Endocardial Combined Approach.

Conditions
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Atrial Fibrillation (AF)

Intervention / Treatment
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* Device: The AtriCure Synergy Ablation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with complex AF defined by the following criteria : AF> 1 week or long term persistent> 1 year AND Symptomatic AND after failure of treatment of anti-arrhythmic or against-indication for anti-arrhythmic Exclusion Criteria: The exclusion criteria are relevant contraindications thoracoscopy or the non-complex nature of the AF: Paroxysmal AF or AF cardioverted anti-arrhythmic test (unless against indicated) Recent AF for which a simple gesture is intracavitary considered sufficient Permanent AF Asymptomatic AF Very old AF (> 5 years) or atrial major ectasia (> 60 mm) Need another surgery (valve bypass coronary) Previous history of sternotomy or thoracotomy High-risk surgical or anesthetic Patient BMI> 35 Sleep Apnea Ejection fraction <35% Thoracic trauma history Veins Pulmonary stenosis> 50% Hyperthyroidism Thrombus in LAA

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>All patients will have the hybrid procedure of ablation of atrial fibrillation. | Device: The AtriCure Synergy Ablation System<br>* The AtriCure Synergy Ablation System will be used on all patients for AF ablation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with complete procedure or not | At the end of the intervention, the doctor evaluates whether the procedure was complete with electric exclusion of the posterior wall of the left atrium and the 4 pulmonary veins. | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of atrial fibrillation episode |  | 12 months | 
| Stroke Rate |  | 12 months | 
| Hospitalization for heart failure | The number of hospitalizations for heart failure after hybrid procedure | 12 months | 
| Evaluation of Quality of life (EQ-5D according to the survey-3L) | The quality of life will be measured using the EQ-5D 3L questionnaire (EQ-5D according to the survey-3L) | 12 months | 
| The cost-effectiveness ration | Cost estimates will be conducted from the perspective of health insurance. The expenses incurred in the care of patients will be counted during the follow-up year. The effectiveness will be assessed against the complications of strategy | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epicardial surgical removal, Closure of the left atrial, Left atrial appendage (LAA)