Status:
COMPLETED
Ablation or Surgery for Atrial Fibrillation (AF) Treatment
Lead Sponsor:
St. Antonius Hospital
Collaborating Sponsors:
Hospital Clinic of Barcelona
AtriCure, Inc.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
30-70 years
Phase:
NA
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 ...
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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00662701
Start Date
May 1 2007
End Date
January 1 2013
Last Update
November 20 2015
Active Locations (2)
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1
St. Antonius Hospital Nieuwegein
Nieuwegein, Netherlands, 3430
2
Hospital Clinic Barcelona
Barcelona, Spain