Medical and Surgical Hybrid Treatment of Atrial Fibrillation.

Atrial Fibrillation (AF) Clinical Trial

— HT2AF  

Official title:

Medical and Surgical Hybrid Treatment of Atrial Fibrillation: Epicardial and Endocardial Combined Approach.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02630914
• Other study ID #: RC31/14/7424
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: March 2018

Study information

• Verified date: December 2018
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation (AF)

Intervention

Device:
• The AtriCure Synergy Ablation System
The AtriCure Synergy Ablation System will be used on all patients for AF ablation.

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse	Midi Pyrenees

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View 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. Review. — View Citation

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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with complete procedure or not	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.	3 hours
Secondary	Number of atrial fibrillation episode		12 months
Secondary	Stroke Rate		12 months
Secondary	Hospitalization for heart failure	The number of hospitalizations for heart failure after hybrid procedure	12 months
Secondary	Evaluation of Quality of life (EQ-5D according to the survey-3L)	The quality of life will be measured using the EQ-5D 3L questionnaire (EQ-5D according to the survey-3L)	12 months
Secondary	The cost-effectiveness ration	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	12 months