Medical and Surgical Hybrid Treatment of Atrial Fibrillation. (HT2AF)

Toulouse University Hospital

Status: Completed

Conditions: Atrial Fibrillation (AF)

Treatments: Device: The AtriCure Synergy Ablation System

Study type: Interventional

Funder types: Other

Identifiers

NCT02630914

RC31/14/7424

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Intervention

Experimental group

Description:

All patients will have the hybrid procedure of ablation of atrial fibrillation.

Treatment:

Device: The AtriCure Synergy Ablation System