Atrial Fibrillation (AF)
Conditions
Keywords
Epicardial surgical removal, Closure of the left atrial, Left atrial appendage (LAA)
Brief summary
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.
Interventions
DEVICEThe AtriCure Synergy Ablation System
The AtriCure Synergy Ablation System will be used on all patients for AF ablation.
Sponsors
University Hospital, Toulouse
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with complete procedure or not | 3 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of atrial fibrillation episode | 12 months | — |
| Stroke Rate | 12 months | — |
| Hospitalization for heart failure | 12 months | The number of hospitalizations for heart failure after hybrid procedure |
| Evaluation of Quality of life (EQ-5D according to the survey-3L) | 12 months | The quality of life will be measured using the EQ-5D 3L questionnaire (EQ-5D according to the survey-3L) |
| The cost-effectiveness ration | 12 months | 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 |
Countries
France
Outcome results
None listed