Medical and Surgical Hybrid Treatment of Atrial Fibrillation.
- Conditions
- Atrial Fibrillation (AF)
- Interventions
- Device: The AtriCure Synergy Ablation System
- Registration Number
- NCT02630914
- Lead Sponsor
- University Hospital, Toulouse
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention The AtriCure Synergy Ablation System All patients will have the hybrid procedure of ablation of atrial fibrillation.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Number of atrial fibrillation episode 12 months Hospitalization for heart failure 12 months The number of hospitalizations for heart failure after hybrid procedure
Stroke Rate 12 months 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
Trial Locations
- Locations (1)
University Hospital Toulouse
🇫🇷Toulouse, Midi Pyrenees, France