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Sponsors and Collaborators: |
St. Antonius Hospital Hospital Clinic of Barcelona AtriCure, Inc. |
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Information provided by: | St. Antonius Hospital |
ClinicalTrials.gov Identifier: | NCT00662701 |
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 | Intervention |
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Atrial Fibrillation |
Procedure: Catheter Ablation Procedure: Surgical Ablation |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Atrial Fibrillation: Ablation or Surgical Treatment; A Randomized Study Comparing Non-Pharmacologic Therapy in Patients With Drug-Refractory Atrial Fibrillation |
Estimated Enrollment: | 120 |
Study Start Date: | May 2007 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
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.
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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.
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2: Active Comparator
Minimal invasive thoracoscopic surgery including isolation of the PVs by AtriCure and removal of the LAA.
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Procedure: Surgical Ablation
Minimal invasive thoracoscopic surgery including isolation of the PVs by AtriCure and removal of the LAA.
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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)
Ages Eligible for Study: | 30 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lucas V Boersma, MD/PhD | 31-30-609-3637 | l.boersma@antonius.net |
Contact: WimJan van Boven, MD | 31-30-609-2108 | w.boven@antonius.net |
Netherlands | |
St. Antonius Hospital Nieuwegein | Recruiting |
Nieuwegein, Netherlands, 3430 | |
Principal Investigator: Lucas Boersma, MD | |
Principal Investigator: WimJan van Boven, MD | |
Spain | |
Hospital Clinic Barcelona | Recruiting |
Barcelona, Spain | |
Principal Investigator: Lluis Mont, MD | |
Principal Investigator: M Castella, MD |
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 Barcelona |
Principal Investigator: | Castella M, MD | Hospital Clinic Barcelona |
Responsible Party: | St. Antonius Hospital Nieuwegein ( L.V.A. Boersma ) |
Study ID Numbers: | R-06.30A/FAST |
Study First Received: | March 25, 2008 |
Last Updated: | April 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00662701 |
Health Authority: | Netherlands: Dutch Health Care Inspectorate |
Atrial Fibrillation |
Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |