Medical and Surgical Hybrid Treatment of Atrial Fibrillation.
NCT ID: NCT02630914
Last Updated: 2018-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2015-09-30
2018-03-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention
All patients will have the hybrid procedure of ablation of atrial fibrillation.
The AtriCure Synergy Ablation System
The AtriCure Synergy Ablation System will be used on all patients for AF ablation.
Interventions
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The AtriCure Synergy Ablation System
The AtriCure Synergy Ablation System will be used on all patients for AF ablation.
Eligibility Criteria
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Inclusion 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Bertrand Marcheix, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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University Hospital Toulouse
Toulouse, Midi Pyrenees, France
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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RC31/14/7424
Identifier Type: -
Identifier Source: org_study_id