- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00662701
Ablation or Surgery for Atrial Fibrillation (AF) Treatment (FAST)
Atrial Fibrillation: Ablation or Surgical Treatment; A Randomized Study Comparing Non-pharmacologic Therapy in Patients With Drug-refractory Atrial Fibrillation
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Nieuwegein, Netherlands, 3430
- St. Antonius Hospital Nieuwegein
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Barcelona, Spain
- Hospital Clinic Barcelona
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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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Active Comparator: 2
Minimal invasive thoracoscopic surgery including isolation of the PVs by AtriCure and removal of the LAA.
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Minimal invasive thoracoscopic surgery including isolation of the PVs by AtriCure and removal of the LAA.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Freedom from AF and/or secondary left atrial arrhythmias, lasting >60 sec, as determined by 7 day continuous Holter monitoring.
Time Frame: 6 months
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6 months
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Safety and/or adverse events
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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6 and 12 Months
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Composite major complications, Serious Adverse Events, Serious Adverse Effects
Time Frame: 12 Months
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12 Months
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Collaborators and Investigators
Sponsor
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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R-06.30A/FAST
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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