Clinical trial NCT01336075: Atrial Fibrillation: Ablation or Surgical Treatment II: FAST II
Official title: Atrial Fibrillation: Ablation or Surgical Treatment II: FAST II A Randomized Study Comparing Non-pharmacologic Therapy in Patients With Drug-refractory Atrial Fibrillation Referred for a First Time Invasive Treatment.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation.
Keywords: Percutaneous radiofrequency catheter ablation
Mini invasive thoracoscopic radiofrequency ablation
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: St. Antonius Hospital
name: Odense University Hospital
First posted: 2011-04-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two invasive treatments of symptomatic paroxysmal atrial fibrillation: Percutaneous radiofrequency catheter ablation and mini invasive thoracoscopic radiofrequency ablation in patients referred for a first time invasive treatment for atrial fibrillation.

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.

Detailed description: Atrial fibrillation is characterized by disorganized, rapid, and irregular contraction of the atria. Its effects on hemodynamic and thromboembolic events result in significant morbidity, mortality, impaired quality of life, hospitalizations, and health-cost.

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.

Eligibility criteria: Inclusion Criteria:

* Recurrent symptomatic paroxysmal atrial fibrillation
* 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:

* Persistent or permanent atrial fibrillation
* 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

Primary outcomes:
measure: Freedom from atrial fibrillation with or without antiarrhythmic drug.
timeFrame: 12 month follow-up
Secondary outcomes:
measure: Quality of life
timeFrame: 12 month follow-up
measure: Procedural complications
timeFrame: 12 month follow-up
measure: Health economics (cost-effectiveness analysis)
timeFrame: 12 month follow-up
measure: Reduction in atrial fibrillation burden
timeFrame: 12 month follow-up
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Dept of Cardiothoracic surgery and Dept of Cardiology, Aalborg Hospital
city: Odense
country: Denmark
facility: Odense Universityhospital
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
Study officials:
affiliation: Aalborg University Hospital
name: Henrik Vadmann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aalborg University Hospital
name: Sam Riahi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aalborg University Hospital
name: Jan Jesper Andreasen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aalborg University Hospital
name: Søren Hjortshøj, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Antonius Hospital
name: Alaaddin Yilmaz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Antonius Hospital
name: Lucas Boersma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Odense Universityhospital
name: Axel Brandes, MD, FESC
role: PRINCIPAL_INVESTIGATOR
affiliation: Odense Universityhospital
name: Peter Pallesen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.