Atrial Fibrillation: Ablation or Surgical Treatment II: FAST II
NCT ID: NCT01336075
Last Updated: 2014-01-03
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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TERMINATED
NA
26 participants
INTERVENTIONAL
2011-04-30
2013-12-31
Brief Summary
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The hypothesis is, that mini invasive thoracoscopic radiofrequency ablation as a first time invasive treatment is more effective compared to a percutaneous catheter based technique in patients with symptomatic paroxysmal atrial fibrillation refractory or intolerant to at least one antiarrhythmic drug.
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Detailed Description
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It is the most common sustained cardiac arrhythmia. Over six million Europeans suffer from this arrhythmia. The prevalence is estimated to at least double in the next 50 years and is probably underestimated due to asymptomatic atrial fibrillation. The prevalence increases with age and affects men more often.
Atrial fibrillation is treated medically with varying results and there are no definitive long term curative treatments. The main goal aims at reducing symptoms and preventing disabling complications. Treatment normally includes antithrombotic, rhythm, and/or rate management, New non-pharmacological interventions have evolved over the last decades in order to prevent paroxysmal atrial fibrillation and/or reduce symptoms. The main focus of non-pharmacological intervention has been on percutaneous radiofrequency catheter ablation and surgical maze ablation. Both approaches aim at minimizing the impact of "triggers" from the pulmonary veins by electrical isolation of the veins.
Studies comparing antiarrhythmic drug and radiofrequency ablation indicate that radiofrequency ablation has a higher efficacy rate, a lower rate of complications, and in selected patients radiofrequency ablation reduced the risk of atrial fibrillation recurrence after one year by 65 % compared with antiarrhythmic drug. In a recently published paper the success rate after a mean of 1.3 radiofrequency ablation procedures per patient varied from 57.7% to 75.4% with higher success rates in patients with paroxysmal atrial fibrillation as compared to persistent/permanent atrial fibrillation.
European Society of Cardiology recommends that radiofrequency ablation is reserved for patients who remain symptomatic despite optimal therapy and failed at least one antiarrhythmic drug.
Dr. James Cox introduced the Cox-maze surgical operation for atrial fibrillation in 1987, later modified to Cox-maze III also known as the "cut and sew" maze. It is highly successful in restoring sinus rhythm, with 90-96 % being free from atrial fibrillation at a mean follow-up of 5.4 years. Due to its complexity and technical difficulty the procedure has not been widely adopted. Mini invasive procedures for pulmonary vein isolation have been developed and can now be performed either through mini thoracotomies or using totally thoracoscopic approach. These procedures also hold the advantage of left atrial appendage excision or exclusion. The thoracoscopic maze ablation has shown promising results in small studies in patients with recurrence of atrial fibrillation after earlier catheter based radiofrequency ablation, after a mean follow-up of 11 months 84 % of the patients remain in sinus rhythm. However long-term results are still unknown. The procedure still needs to be compared head to head with catheter based radiofrequency ablation before it should be offered as a standard treatment of atrial fibrillation.
The rationale for eliminating atrial fibrillation with radiofrequency ablation include a potential improvement in quality of life, decreased stroke risk, decreased heart failure risk and improved survival.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Mini invasive thoracoscopic radiofrequency ablation
Video-assisted thoracoscopic radiofrequency ablation
Mini invasive thoracoscopic radiofrequency ablation
Video-assisted thoracoscopic approach for electrical isolation of the pulmonary veins bilaterally and left atrial appendage excision or exclusion.
Percutaneous ablation
Percutaneous radiofrequency catheter ablation
Percutaneous radiofrequency catheter ablation
Percutaneous radiofrequency catheter ablation around the rights and lefts pulmonary veins, with complete circumferential ablation.
Interventions
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Percutaneous radiofrequency catheter ablation
Percutaneous radiofrequency catheter ablation around the rights and lefts pulmonary veins, with complete circumferential ablation.
Mini invasive thoracoscopic radiofrequency ablation
Video-assisted thoracoscopic approach for electrical isolation of the pulmonary veins bilaterally and left atrial appendage excision or exclusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Previously failed one or more antiarrhythmic or beta-blocker medication (treatment \> 30 days) or if any contraindications against treatment with these drug.
* Patient is willing and able to attend the scheduled follow-up visits
* Signed informed consent
Exclusion Criteria
* Previously atrial fibrillation ablation procedure
* Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
* Severe underlying heart disease (congenital heart disease, significant valvular disease, cardiomyopathy with LVEF \< 35 %, angina pectoris/ ischemic heart disease).
* Severe enlargement of left atrium (\> 45mm)
* Patient with pacemaker
* Failure to obtain informed consent
* Pregnant or breastfeeding women.
* Patient unable to undergo TEE or with documented left atrial thrombus
* Patients with co-morbid conditions who, in the opinion of the investigator, constitute increased risk of general anesthesia or port access, e.g. pleural fibrosis, chronic obstructive pulmonary disease (FEV1 \< 1.5 L/s).
* Known internal carotid artery stenosis (\> 80 %).
* Patients, who are enrolled in another clinical trial
* Life expectancy less than one year
* Previously TIA/stroke
18 Years
75 Years
ALL
No
Sponsors
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St. Antonius Hospital
OTHER
Odense University Hospital
OTHER
Aalborg University Hospital
OTHER
Responsible Party
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Henrik Vadmann, MD, Ph.d student.
MD, Ph.D. student
Principal Investigators
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Henrik Vadmann, MD
Role: PRINCIPAL_INVESTIGATOR
Aalborg University Hospital
Sam Riahi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Aalborg University Hospital
Jan Jesper Andreasen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Aalborg University Hospital
Søren Hjortshøj, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Aalborg University Hospital
Alaaddin Yilmaz, MD
Role: PRINCIPAL_INVESTIGATOR
St. Antonius Hospital
Lucas Boersma, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Antonius Hospital
Axel Brandes, MD, FESC
Role: PRINCIPAL_INVESTIGATOR
Odense Universityhospital
Peter Pallesen, MD
Role: PRINCIPAL_INVESTIGATOR
Odense Universityhospital
Locations
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Dept of Cardiothoracic surgery and Dept of Cardiology, Aalborg Hospital
Aalborg, , Denmark
Odense Universityhospital
Odense, , Denmark
St. Antonius Hospital
Nieuwegein, , Netherlands
Countries
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References
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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; ESC Committee for Practice Guidelines. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Europace. 2010 Oct;12(10):1360-420. doi: 10.1093/europace/euq350. No abstract available.
Yilmaz A, Geuzebroek GS, Van Putte BP, Boersma LV, Sonker U, De Bakker JM, Van Boven WJ. Completely thoracoscopic pulmonary vein isolation with ganglionic plexus ablation and left atrial appendage amputation for treatment of atrial fibrillation. Eur J Cardiothorac Surg. 2010 Sep;38(3):356-60. doi: 10.1016/j.ejcts.2010.01.058. Epub 2010 Mar 12.
Nair GM, Nery PB, Diwakaramenon S, Healey JS, Connolly SJ, Morillo CA. A systematic review of randomized trials comparing radiofrequency ablation with antiarrhythmic medications in patients with atrial fibrillation. J Cardiovasc Electrophysiol. 2009 Feb;20(2):138-44. doi: 10.1111/j.1540-8167.2008.01285.x. Epub 2008 Sep 3.
Lafuente-Lafuente C, Mouly S, Longas-Tejero MA, Bergmann JF. Antiarrhythmics for maintaining sinus rhythm after cardioversion of atrial fibrillation. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD005049. doi: 10.1002/14651858.CD005049.pub2.
Schilling RJ. Cardioversion of atrial fibrillation: the use of antiarrhythmic drugs. Heart. 2010 Mar;96(5):333-8. doi: 10.1136/hrt.2008.155812. Epub 2009 Nov 11.
Calkins H, Reynolds MR, Spector P, Sondhi M, Xu Y, Martin A, Williams CJ, Sledge I. Treatment of atrial fibrillation with antiarrhythmic drugs or radiofrequency ablation: two systematic literature reviews and meta-analyses. Circ Arrhythm Electrophysiol. 2009 Aug;2(4):349-61. doi: 10.1161/CIRCEP.108.824789. Epub 2009 Jun 2.
Cappato R, Calkins H, Chen SA, Davies W, Iesaka Y, Kalman J, Kim YH, Klein G, Natale A, Packer D, Skanes A, Ambrogi F, Biganzoli E. Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circ Arrhythm Electrophysiol. 2010 Feb;3(1):32-8. doi: 10.1161/CIRCEP.109.859116. Epub 2009 Dec 7.
Cox JL. Cardiac surgery for arrhythmias. J Cardiovasc Electrophysiol. 2004 Feb;15(2):250-62. doi: 10.1046/j.1540-8167.2004.03656.x.
Gaynor SL, Diodato MD, Prasad SM, Ishii Y, Schuessler RB, Bailey MS, Damiano NR, Bloch JB, Moon MR, Damiano RJ Jr. A prospective, single-center clinical trial of a modified Cox maze procedure with bipolar radiofrequency ablation. J Thorac Cardiovasc Surg. 2004 Oct;128(4):535-42. doi: 10.1016/j.jtcvs.2004.02.044.
Shen J, Bailey M, Damiano RJ Jr. Surgery for Lone Atrial Fibrillation: Present State-of-the-Art. Innovations (Phila). 2009 Oct;4(5):248-255. doi: 10.1097/IMI.0b013e3181bb370f.
Sindby JE, Vadmann H, Lundbye-Christensen S, Riahi S, Hjortshoj S, Boersma LVA, Andreasen JJ. Percutaneous versus thoracoscopic ablation of symptomatic paroxysmal atrial fibrillation: a randomised controlled trial - the FAST II study. J Cardiothorac Surg. 2018 Oct 3;13(1):101. doi: 10.1186/s13019-018-0792-8.
Other Identifiers
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FAST II
Identifier Type: -
Identifier Source: org_study_id
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