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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
Sponsor:
Collaborators:
St. Antonius Hospital
Odense University Hospital
Information provided by (Responsible Party):
Henrik Vadmann, MD, Ph.d student., Aalborg University Hospital

Tracking Information
First Submitted Date  ICMJE April 13, 2011
First Posted Date  ICMJE April 15, 2011
Last Update Posted Date January 3, 2014
Study Start Date  ICMJE April 2011
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Atrial Fibrillation: Ablation or Surgical Treatment II: FAST II
Official Title  ICMJE 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Paroxysmal Atrial Fibrillation.
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Mini invasive thoracoscopic radiofrequency ablation
    Video-assisted thoracoscopic radiofrequency ablation
    Intervention: Procedure: Mini invasive thoracoscopic radiofrequency ablation
  • Active Comparator: Percutaneous ablation
    Percutaneous radiofrequency catheter ablation
    Intervention: Procedure: Percutaneous radiofrequency catheter ablation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 2, 2014)
26
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2011)
180
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01336075
Other Study ID Numbers  ICMJE FAST II
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Henrik Vadmann, MD, Ph.d student., Aalborg University Hospital
Study Sponsor  ICMJE Aalborg University Hospital
Collaborators  ICMJE
  • St. Antonius Hospital
  • Odense University Hospital
Investigators  ICMJE
Principal Investigator: Henrik Vadmann, MD Aalborg University Hospital
Principal Investigator: Sam Riahi, MD, PhD Aalborg University Hospital
Principal Investigator: Jan Jesper Andreasen, MD, PhD Aalborg University Hospital
Principal Investigator: Søren Hjortshøj, MD, PhD Aalborg University Hospital
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
PRS Account Aalborg University Hospital
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP