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Trial record 18 of 39 for:    atricure

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

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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

Tracking Information
First Submitted Date  ICMJE March 25, 2008
First Posted Date  ICMJE April 21, 2008
Last Update Posted Date November 20, 2015
Study Start Date  ICMJE May 2007
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  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 Ablation or Surgery for Atrial Fibrillation (AF) Treatment
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • 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  ICMJE
  • 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.

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

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 70 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 Netherlands,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00662701
Other Study ID Numbers  ICMJE R-06.30A/FAST
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lucas Boersma, St. Antonius Hospital
Study Sponsor  ICMJE St. Antonius Hospital
Collaborators  ICMJE
  • Hospital Clinic of Barcelona
  • AtriCure, Inc.
Investigators  ICMJE
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

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