Atrial Fibrillation: Ablation or Surgical Treatment II: FAST II

This study has been terminated.
(Too few participants)
Sponsor:
Collaborators:
St. Antonius Hospital
Odense University Hospital
Information provided by (Responsible Party):
Henrik Vadmann, MD, Ph.d student., Aalborg Universityhospital
ClinicalTrials.gov Identifier:
NCT01336075
First received: April 13, 2011
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

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 Intervention
Paroxysmal Atrial Fibrillation.
Procedure: Percutaneous radiofrequency catheter ablation
Procedure: Mini invasive thoracoscopic radiofrequency ablation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Aalborg Universityhospital:

Primary Outcome Measures:
  • Freedom from atrial fibrillation with or without antiarrhythmic drug. [ Time Frame: 12 month follow-up ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 12 month follow-up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Reduction in atrial fibrillation burden [ Time Frame: 12 month follow-up ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: April 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • Radiofrequency ablation
  • Catheter ablation
  • Atrial fibrillation ablation

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01336075

Locations
Denmark
Dept of Cardiothoracic surgery and Dept of Cardiology, Aalborg Hospital
Aalborg, Denmark, 9000
Odense Universityhospital
Odense, Denmark, 5000
Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands, 3430
Sponsors and Collaborators
Aalborg Universityhospital
St. Antonius Hospital
Odense University Hospital
Investigators
Principal Investigator: Henrik Vadmann, MD Aalborg Universityhospital
Principal Investigator: Sam Riahi, MD, PhD Aalborg Universityhospital
Principal Investigator: Jan Jesper Andreasen, MD, PhD Aalborg Universityhospital
Principal Investigator: Søren Hjortshøj, MD, PhD Aalborg Universityhospital
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
  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; ESC Committee for Practice Guidelines; Vahanian A, Auricchio A, Bax J, Ceconi C, Dean V, Filippatos G, Funck-Brentano C, Hobbs R, Kearney P, McDonagh T, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Vardas PE, Widimsky P; Document Reviewers; Vardas PE, Agladze V, Aliot E, Balabanski T, Blomstrom-Lundqvist C, Capucci A, Crijns H, Dahlöf B, Folliguet T, Glikson M, Goethals M, Gulba DC, Ho SY, Klautz RJ, Kose S, McMurray J, Perrone Filardi P, Raatikainen P, Salvador MJ, Schalij MJ, Shpektor A, Sousa J, Stepinska J, Uuetoa H, Zamorano JL, Zupan I. 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. No abstract available.

Responsible Party: Henrik Vadmann, MD, Ph.d student., MD, Ph.D. student, Aalborg Universityhospital
ClinicalTrials.gov Identifier: NCT01336075     History of Changes
Other Study ID Numbers: FAST II
Study First Received: April 13, 2011
Last Updated: January 2, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Aalborg Universityhospital:
Percutaneous radiofrequency catheter ablation
Mini invasive thoracoscopic radiofrequency ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014