Clinical trial NCT02630914: Medical and Surgical Hybrid Treatment of Atrial Fibrillation.
Official title: Medical and Surgical Hybrid Treatment of Atrial Fibrillation: Epicardial and Endocardial Combined Approach.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation (AF)
Keywords: Epicardial surgical removal
Closure of the left atrial
Left atrial appendage (LAA)
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2015-12-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with complete procedure or not
timeFrame: 3 hours
Secondary outcomes:
measure: Number of atrial fibrillation episode
timeFrame: 12 months
measure: Stroke Rate
timeFrame: 12 months
measure: Hospitalization for heart failure
timeFrame: 12 months
measure: Evaluation of Quality of life (EQ-5D according to the survey-3L)
timeFrame: 12 months
measure: The cost-effectiveness ration
timeFrame: 12 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
state: Midi Pyrenees
Study officials:
affiliation: University Hospital, Toulouse
name: Bertrand Marcheix, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: European Heart Rhythm Association; European Association for Cardio-Thoracic Surgery; Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010 Oct;31(19):2369-429. doi: 10.1093/eurheartj/ehq278. Epub 2010 Aug 29. No abstract available.
citation: Rich MW. Epidemiology of atrial fibrillation. J Interv Card Electrophysiol. 2009 Jun;25(1):3-8. doi: 10.1007/s10840-008-9337-8. Epub 2009 Jan 22.
citation: Pison L, Gelsomino S, Luca F, Parise O, Maessen JG, Crijns HJ, La Meir M. Effectiveness and safety of simultaneous hybrid thoracoscopic and endocardial catheter ablation of lone atrial fibrillation. Ann Cardiothorac Surg. 2014 Jan;3(1):38-44. doi: 10.3978/j.issn.2225-319X.2013.12.10.
citation: Pison L. Breakthroughs in hybrid management of stand-alone AF. Ann Cardiothorac Surg. 2014 Jan;3(1):78-9. doi: 10.3978/j.issn.2225-319X.2013.12.05. No abstract available.
citation: Gelsomino S, Van Breugel HN, Pison L, Parise O, Crijns HJ, Wellens F, Maessen JG, La Meir M. Hybrid thoracoscopic and transvenous catheter ablation of atrial fibrillation. Eur J Cardiothorac Surg. 2014 Mar;45(3):401-7. doi: 10.1093/ejcts/ezt385. Epub 2013 Jul 31.