Medical and Surgical Hybrid Treatment of Atrial Fibrillation.

University Hospital, Toulouse12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation (AF)

Interventions

The AtriCure Synergy Ablation SystemDEVICE

The AtriCure Synergy Ablation System will be used on all patients for AF ablation.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Toulouse

Toulouse, Midi Pyrenees, France

Outcomes

Primary Outcomes

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.

Time frame: 3 hours

Secondary Outcomes

Number of atrial fibrillation episode

Time frame: 12 months

Stroke Rate

Time frame: 12 months

Hospitalization for heart failure

The number of hospitalizations for heart failure after hybrid procedure

Time frame: 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)

Time frame: 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

Time frame: 12 months

Data from ClinicalTrials.gov

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