HT2AF: Medical and Surgical Hybrid Treatment of Atrial Fibrillation.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention All patients will have the hybrid procedure of ablation of atrial fibrillation. |
Device: The AtriCure Synergy Ablation System
The AtriCure Synergy Ablation System will be used on all patients for AF ablation.
|
Outcome Measures
Primary Outcome Measures
- 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
- Number of atrial fibrillation episode [12 months]
- Stroke Rate [12 months]
- Hospitalization for heart failure [12 months]
The number of hospitalizations for heart failure after hybrid procedure
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
patients with complex AF defined by the following criteria :
-
AF> 1 week or long term persistent> 1 year
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AND Symptomatic
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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:
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Paroxysmal AF or AF cardioverted anti-arrhythmic test (unless against indicated)
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Recent AF for which a simple gesture is intracavitary considered sufficient
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Permanent AF
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Asymptomatic AF
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Very old AF (> 5 years) or atrial major ectasia (> 60 mm)
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Need another surgery (valve bypass coronary)
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Previous history of sternotomy or thoracotomy
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High-risk surgical or anesthetic Patient
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BMI> 35
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Sleep Apnea
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Ejection fraction <35%
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Thoracic trauma history
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Veins Pulmonary stenosis> 50%
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Hyperthyroidism
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Thrombus in LAA
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Toulouse | Toulouse | Midi Pyrenees | France | 31059 |
Sponsors and Collaborators
- University Hospital, Toulouse
Investigators
- Principal Investigator: Bertrand Marcheix, MD, University Hospital, Toulouse
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Erratum in: Eur Heart J. 2011 May;32(9):1172.
- 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. Review.
- Pison L, Gelsomino S, Lucà 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.
- 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. Review.
- RC31/14/7424