Medical and Surgical Hybrid Treatment of Atrial Fibrillation.

Not Applicable

Completed

• Conditions: Atrial Fibrillation (AF)

• 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

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-12-11
• Study First Submitted QC: 2015-12-11
• Study First Posted: 2015-12-15
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-18
• Last Update Posted: 2018-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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
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
Hospitalization for heart failure	12 months	The number of hospitalizations for heart failure after hybrid procedure
Number of atrial fibrillation episode	12 months

Trial Locations

Locations (1)

University Hospital Toulouse; 🇫🇷 Toulouse, Midi Pyrenees, France