Ablation or Surgery for Atrial Fibrillation (AF) Treatment (FAST)

• ClinicalTrials.gov Identifier: NCT00662701
• Recruitment Status: Completed
• First Posted: April 21, 2008
• Last Update Posted: November 20, 2015
• Sponsor: St. Antonius Hospital
• Collaborators: Hospital Clinic of Barcelona; AtriCure, Inc.
• Information provided by (Responsible Party): Lucas Boersma, St. Antonius Hospital

Tracking Information

• First Submitted Date: March 25, 2008
• First Posted Date: April 21, 2008
• Last Update Posted Date: November 20, 2015
• Study Start Date: May 2007
• Actual Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 17, 2008)

• Freedom from AF and/or secondary left atrial arrhythmias, lasting >60 sec, as determined by 7 day continuous Holter monitoring. [ Time Frame: 6 months ]
• Safety and/or adverse events [ Time Frame: 6 months ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 17, 2008)

• Freedom of AADs, Decrease in the frequency and duration of AF episodes, Decrease in the number of AF related hospital admissions, Improvement in quality of life internet Follow Up, Decrease in number of cardioversions, PM implant [ Time Frame: 6 and 12 Months ]
• Composite major complications, Serious Adverse Events, Serious Adverse Effects [ Time Frame: 12 Months ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ablation or Surgery for Atrial Fibrillation (AF) Treatment
• Official Title: Atrial Fibrillation: Ablation or Surgical Treatment; A Randomized Study Comparing Non-pharmacologic Therapy in Patients With Drug-refractory Atrial Fibrillation
• Brief Summary: The purpose of this study is to compare 2 invasive strategies for Atrial Fibrillation treatment, Endocardial catheter ablation isolation of the Pulmonary veins versus minimally invasive thoracoscopic surgical epicardial isolation. Both strategies are in use for several years now, and have been reported as a successful strategy with success rates of 60-90%. However, it is not known which technique is preferable in a given patient population in terms of efficacy to cure AF, safety, or patient discomfort. Therefore, in the present trial a randomized study is proposed to provide more insight into the relative merits of both techniques

Detailed Description

Atrial Fibrillation is the most common cardiac arrhythmia, affecting millions of people around the world. It is a large burden on health care resources and may even lead to a shorter life expectancy. Drug treatment has been found insufficient and sometimes even hazardous to the pt. Traditionally, there was only one invasive approach available, being MAZE 3 procedure by means of full open chest cardiac surgery. This was a very invasive approach, limited to only a few skilled surgeons, with insufficient options to treat large pt volume.

With the discovery that AF often is initiated and maintained by electrical instability inside and around the Pulmonary Veins, catheter ablation is now a widely accepted early invasive strategy to cure AF. Success rates of 60% to 90% have been reported, depending on technique employed and the type of AF (Resp, chronic versus paroxysmal)

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Atrial Fibrillation

Intervention

• Procedure: Catheter Ablation
  RF ablation with complete circumferential ablation around the right and PVs, optional additional lines between the lower and upper PVs, and towards the mitral valve ring.
• Procedure: Surgical Ablation
  Minimal invasive thoracoscopic surgery including isolation of the PVs by AtriCure and removal of the LAA.

Study Arms

• Active Comparator: 1
  Catheter RF ablation with complete circumferential ablation around the right and PVs, and additional lines between the lower and upper PVs, and towards the mitral valve ring.
  Intervention: Procedure: Catheter Ablation
• Active Comparator: 2
  Minimal invasive thoracoscopic surgery including isolation of the PVs by AtriCure and removal of the LAA.
  Intervention: Procedure: Surgical Ablation

• Publications *: Boersma LV, Castella M, van Boven W, Berruezo A, Yilmaz A, Nadal M, Sandoval E, Calvo N, Brugada J, Kelder J, Wijffels M, Mont L. Atrial fibrillation catheter ablation versus surgical ablation treatment (FAST): a 2-center randomized clinical trial. Circulation. 2012 Jan 3;125(1):23-30. doi: 10.1161/CIRCULATIONAHA.111.074047. Epub 2011 Nov 14.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 17, 2008): 120
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: January 2013
• Actual Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patient has a history of symptomatic paroxysmal and/or persistent atrial fibrillation for at least 12 months
• Patient is refractory to or intolerant of at least one antiarrhythmic drug
• Patient has an enlarged atrium >40 mm and/or Patient has a failed previous catheter ablation and/or Patient has additional risk factors such as hypertension, increasing age
• Patient is between 30 and 70 years of age
• Patient is mentally able and willing to give informed consent

Exclusion Criteria:

• Cardiac ablation or surgical cardiac procedure in the last 3 months
• Previous cardiac tamponade
• Previous stroke or TIA
• Left atrial thrombus
• Left atrial size >65 mm
• Left ventricular ejection fraction <45 %
• Active infection or sepsis
• Pregnancy
• Unstable angina
• Myocardial infarction (MI) within previous 3 months
• Atrial fibrillation is secondary to electrolyte imbalance, thyroid disease, or other reversible or non-cardiovascular cause
• History of blood clotting abnormalities
• Known sensitivity to heparin or warfarin
• Life expectancy is less than 12 months
• Patient is involved in another clinical study involving an investigational drug or device
• Pleural adhesions
• Prior thoracotomy
• Prior cardiac surgery
• Elevated hemi diaphragm

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands, Spain

Administrative Information

• NCT Number: NCT00662701
• Other Study ID Numbers: R-06.30A/FAST
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Lucas Boersma, St. Antonius Hospital
• Original Responsible Party: L.V.A. Boersma, St. Antonius Hospital Nieuwegein
• Current Study Sponsor: St. Antonius Hospital
• Original Study Sponsor: Same as current

Collaborators

• Hospital Clinic of Barcelona
• AtriCure, Inc.

Investigators

• Principal Investigator: Lucas Boersma, MD/PhD; ST. Antonius hospital Nieuwegein
• Principal Investigator: WimJan van Boven, MD; ST. Antonius hospital Nieuwegein
• Principal Investigator: Lluis Mont, MD; Hospital Clinic of Barcelona
• Principal Investigator: Castella M, MD; Hospital Clinic of Barcelona

• PRS Account: St. Antonius Hospital
• Verification Date: November 2015