Atrial Fibrillation: Ablation or Surgical Treatment II: FAST II
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01336075|
Recruitment Status : Terminated (Too few participants)
First Posted : April 15, 2011
Last Update Posted : January 3, 2014
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.
|Condition or disease||Intervention/treatment|
|Paroxysmal Atrial Fibrillation.||Procedure: Percutaneous radiofrequency catheter ablation Procedure: Mini invasive thoracoscopic radiofrequency ablation|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Start Date :||April 2011|
|Primary Completion Date :||December 2013|
|Study Completion Date :||December 2013|
Active Comparator: Mini invasive thoracoscopic radiofrequency ablation
Video-assisted thoracoscopic radiofrequency ablation
Procedure: 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 Name: Mini invasive mini maze
Active Comparator: Percutaneous ablation
Percutaneous radiofrequency catheter ablation
Procedure: Percutaneous radiofrequency catheter ablation
Percutaneous radiofrequency catheter ablation around the rights and lefts pulmonary veins, with complete circumferential ablation.
- Freedom from atrial fibrillation with or without antiarrhythmic drug. [ Time Frame: 12 month follow-up ]Determined by seven days Holter monitoring, ECG, and patient interviews. An episode of atrial fibrillation/flutter/tachycardia is defined as more than 30 seconds of atrial fibrillation observed on Holter monitoring/telemetry or ECG
- Quality of life [ Time Frame: 12 month follow-up ]Comparison of quality of life before ablation and at follow-up, by 4 different quality of life questionnaires AFEQT, AF-QoL-18, GAD-7 and PHQ-9.
- Procedural complications [ Time Frame: 12 month follow-up ]Thromboembolic events (TIA,Stroke), Mortality, Tamponade, need for thoracotomy, bleeding, infection, esophageal fistula, embolic events, death , pneumothorax and hemothorax.
- Health economics (cost-effectiveness analysis) [ Time Frame: 12 month follow-up ]
- Reduction in atrial fibrillation burden [ Time Frame: 12 month follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01336075
|Dept of Cardiothoracic surgery and Dept of Cardiology, Aalborg Hospital|
|Aalborg, Denmark, 9000|
|Odense, Denmark, 5000|
|St. Antonius Hospital|
|Nieuwegein, Netherlands, 3430|
|Principal Investigator:||Henrik Vadmann, MD||Aalborg Universitetshospital|
|Principal Investigator:||Sam Riahi, MD, PhD||Aalborg Universitetshospital|
|Principal Investigator:||Jan Jesper Andreasen, MD, PhD||Aalborg Universitetshospital|
|Principal Investigator:||Søren Hjortshøj, MD, PhD||Aalborg Universitetshospital|
|Principal Investigator:||Alaaddin Yilmaz, MD||St. Antonius Hospital, Nieuwegein|
|Principal Investigator:||Lucas Boersma, MD, PhD||St. Antonius Hospital, Nieuwegein|
|Principal Investigator:||Axel Brandes, MD, FESC||Odense Universityhospital|
|Principal Investigator:||Peter Pallesen, MD||Odense Universityhospital|