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

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

Study Description
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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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Catheter Ablation Procedure: Surgical Ablation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Atrial Fibrillation: Ablation or Surgical Treatment; A Randomized Study Comparing Non-pharmacologic Therapy in Patients With Drug-refractory Atrial Fibrillation
Study Start Date : May 2007
Actual Primary Completion Date : November 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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.
Active Comparator: 2
Minimal invasive thoracoscopic surgery including isolation of the PVs by AtriCure and removal of the LAA.
 Procedure: Surgical Ablation
Minimal invasive thoracoscopic surgery including isolation of the PVs by AtriCure and removal of the LAA.


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

Secondary Outcome Measures :
  1. 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 ]
  2. Composite major complications, Serious Adverse Events, Serious Adverse Effects [ Time Frame: 12 Months ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00662701


Locations
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Netherlands
St. Antonius Hospital Nieuwegein
Nieuwegein, Netherlands, 3430
Spain
Hospital Clinic Barcelona
Barcelona, Spain
Sponsors and Collaborators
St. Antonius Hospital
Hospital Clinic of Barcelona
AtriCure, Inc.
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Lucas Boersma, Cardiologist, St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT00662701    
Other Study ID Numbers: R-06.30A/FAST
First Posted: April 21, 2008    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015
Keywords provided by Lucas Boersma, St. Antonius Hospital:
Atrial Fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes